Catheter devices with valves and related methods

ABSTRACT

Needle assemblies and related methods in which a valve opener is used to push into a valve to open one or more slits on the valve to open the valve. The needle assemblies each includes a needle hub with a needle, a catheter tube with a catheter hub and the valve and valve opener positioned in the interior cavity of the catheter hub. The valve can have a valve skirt and a nose section of the valve opener can locate therein. One or more reliefs can be provided with the valve opener so that an elbow or diagonal section on a needle guard can project from a holding space within the valve opener through the relief.

FIELD OF ART

The disclosed invention generally relates to needle devices, arterialcatheters and intravenous (IV) infusion devices, including IV catheters.In particular, IV catheter assemblies having a valve and a valveactuator for opening the valve are disclosed.

BACKGROUND

IV catheters are commonly used for a variety of infusion therapies,including infusing fluids into a patient, withdrawing blood from apatient, or monitoring various parameters of the patient's vascularsystem. Catheters are typically connected to a catheter adapter thataccommodates the attachment of IV tubing to the catheter. Blood controlcatheters include an internal blood control valve that is opened by theinsertion of a male Luer or other object into a proximal end of thecatheter adapter. Non-limiting examples of blood control valves aredisclosed in United States Patent Application Publication No.2011/0046570, filed Aug. 20, 2009, titled “Systems and Methods forProviding a Flushable Catheter Assembly.” Following placement of thecatheter into the vasculature of a patient, an IV fluid source can beconnected to the catheter adapter or catheter hub, opening the bloodcontrol valve. Thus connected, fluid from the IV source can begin flowinto a patient through the catheter.

As is well known in the art, typical blood pressure is 10 to 20centimeters of water. Infusion bags are usually placed about 100 cmabove the patient's heart to direct flow into the patient. At roughlythat height, the pressure exerted by the fluid from the infusion bag ismuch greater than the blood pressure of the patient and therefore canflow into the patient.

Some catheter adapters permit verification of proper placement of thecatheter in the blood vessel before fluid infusion begins, such as byproviding a flashback chamber of the catheter assembly where a“flashback” of blood can be observed. To confirm flashback in catheterassemblies that do not include a blood control valve, a clinician mustmanually occlude the vein to prevent undesirable exposure to blood. Incontrast, blood control valves can eliminate the need for such manualocclusion, while also reducing the likelihood of blood exposure duringcatheter placement.

SUMMARY

An aspect of the present disclosure can include the provision for acompact design for a valve housing of a Luer activated valve.

Another aspect of the present disclosure can include the provision for arelatively strong construction for use with high pressure injectiondevices.

A still further aspect of the present disclosure can include theprovision for improving the state of the art of blood control or closedsystem infusion devices including intravenous catheters.

As described, a needle assembly of the present disclosure can include anumber of different components. The needle assembly can comprise aneedle hub with a needle extending from a distal end of the needle hub;a catheter tube attached to a catheter hub and having the needleextending through the catheter tube in a ready to use position; a valvepositioned in an interior cavity of the catheter hub, said valvecomprising an outer perimeter that axially floats when moved by aproximal valve opener, which can also be positioned in the interiorcavity of the catheter hub and proximal of the valve. A distal valveopener can further be provided having two or more leg extensionsextending in a proximal direction of a body of a bushing. The valve canbe actuated by both the proximal and distal valve openers.

The valve can have an outer perimeter that is axially fixed within theinterior of the catheter hub. The valve can be opened with just aproximal valve opener. For example, the proximal valve opener can moveinto the valve by a male Luer tip to deflect one or more flaps on thevalve.

Any part of a valve can be axially fixed by the interior surfacestructure of a catheter hub.

The needle assembly wherein two or more leg extensions of a distal valveopener can be axially fixed inside the interior cavity of a catheterhub.

The needle assembly wherein a valve can comprise three slits and threeflaps and wherein a distal valve opener can comprise three legextensions. The three leg extensions can have axially extending edgesthat are spaced from one another. The axially extending edges can beparallel to one another.

The needle assembly wherein three leg extensions can be aligned withthree flaps of a valve.

The needle assembly wherein a proximal valve opener can comprise a ringor nose section and two plunger elements with a gap therebetween. Thering or nose section can comprise an activation or actuation end. Astabilizer ring can be located proximally of the nose section. Thestabilizing ring can have a continuous perimeter section defining abore.

The nose section of the valve opener can comprise a continuous perimetersection.

The valve opener can comprise one, two, or more than two reliefs orthrough passages.

A needle guard located within a holding space of a valve opener canextend through a relief or through passage of the valve opener tocontact an interior of a catheter hub or to contact a perimeter of therelief or through passage. The needle guard can also project through oneor two reliefs of a valve opener without touching the interior of thecatheter hub or touch any perimeter of the valve opener.

When a needle guard is positioned within a holding space of a valveopener, the needle guard can have a proximal wall that is flush with aproximal most end of the valve opener, positioned distally of theproximal most end, or positioned proximally of the proximal most end.When so positioned, an elbow of the needle guard can project through arelief or through passage of the valve opener. If the needle guard hastwo elbows on two deflectable arms, both elbows can project through tworeliefs of the valve opener, one elbow for each relief.

There can be two or more reliefs or through passages of a valve openerand a needle guard can extend through the two or more reliefs or throughpassages or contact the two or more perimeters of the two or morereliefs or through passages.

A needle guard can comprise a resilient arm located at least in partinside a holding space of a valve opener with a first through passageand a second through passage. The needle guard can comprise an elbowprojecting through the first through passage, projecting through thefirst through passage and in contact with a section of a perimeter ofthe first through passage, projecting through the first through passageand in contact with the interior surface of a catheter hub, or acombination of projecting through the first through passage and incontact with the section of the perimeter of the first through passageand the interior surface of the catheter hub.

The needle assembly of the present disclosure can comprise a tipprotector located at least in part in a gap of two plunger elements of avalve opener. The gap of the valve opener can define a holding space foraccommodating at least part of a needle guard or tip protector.

A tip protector can be optionally and the needle assembly can bepracticed without the tip protector.

A tip protector can be unitarily formed or formed by integratingmultiple pieces or components together. The tip protector can have onearm or two arms. The two arms can extend on different sides of a needleor can cross one another, such as intersect one another when viewingfrom a side.

The needle assembly wherein sections of a valve can be deflectable in adistal direction and sections of the valve can be deflectable in aproximal direction to open a fluid flow path through the valve.

The needle assembly wherein the sections of the valve that can bedeflected in the distal direction can comprise outer edges of the valveand sections of the valve that can be deflected in a proximal directioncan be flaps formed with the valve. The flaps can be formed on a valvedisc. The flaps can be formed by incorporating one or more slits.

The needle assembly wherein the body of the bushing and one or more legextensions can be integral. In some examples, the body of the bushing,such as the base or funnel section of the bushing, can be unitarilyformed with one or more leg extensions. Each leg extension can have anose section. In some examples, one leg extension is incorporated, whichcan have a wall defining a bore.

In an example, only part of a tip protector or needle guard can extendinto one or more gaps of a valve opener while a proximal section of thetip protector can extend proximally of the proximal most surfaces of thetip protector. For example, part of the needle guard can overlap withthe valve opener along an axial direction while a proximal section ofthe tip protector, such as the proximal wall, extends proximally or belocated proximally of the proximal most surfaces of the valve opener.

In an example, only part of a tip protector or needle guard can extenddistally of a stabilizing ring of a valve opener and while a proximalsection of the tip protector can extend proximally of the stabilizingring. The part of the tip protector that is located distally of thestabilizing ring can comprise one or two elbows. The one or two elbowscan project through one or two reliefs in the valve opener.

A still further aspect of the present disclosure can include a method ofmanufacturing a needle assembly, such as a catheter assembly. The methodcan comprise: providing a catheter hub with a catheter tube with adistal opening, said catheter hub comprising a hub body defining aninterior cavity and a proximal opening; positioning a bushing inside thecatheter hub and against the catheter tube and positioning a valveproximal of the bushing; the valve being floatable inside the interiorcavity of the catheter hub along an axial direction of the catheter huband comprises two or more flaps; positioning a proximal valve openerproximal of the valve and inside the interior cavity of the catheterhub; placing a needle, which is attached to a needle hub, through thecatheter hub, the valve, and the catheter tube so that a tip of theneedle extends out the distal opening of the catheter tube; and whereintwo or more leg extensions extend in a proximal direction of a body ofthe bushing.

The method wherein the two or more leg extensions of a distal valveopener can be aligned with the two or more flaps on the valve.Optionally, a single leg extension can abut a valve disc from a distalside of the valve disc.

The method wherein a proximal valve opener can comprise a ring or nosesection and at least one plunger element. A stabilizing ring can belocated proximally of the at least one plunger element. In someexamples, there can be two or more plunger elements and the stabilizingring is located proximally of the two or more plunger elements.

A nose section or ring of a valve opener can comprise an activation oractuation end. The nose section can define a bore. Fluid can flowthrough the bore. A needle can pass through the bore of the nose sectionin a ready to use position.

The method wherein a proximal valve opener can comprise two spaced apartplunger elements having a gap therebetween. The gap can define a holdingspace.

The method wherein a needle guard can be located at least in part in thegap and between the two plunger elements.

The method wherein two or more leg extensions of a distal valve openercan be fixed along an axial direction.

The method wherein a proximal valve opener can be slidable in a distaldirection to move a valve having two or more flaps in a distal directionagainst one or more leg extensions. The valve can have three slits andthree flaps. The three slits can converge at a single point. The valvecan have a valve skirt extending proximally of a valve disc.

The valve skirt of a valve can define a valve cavity. The valve cavitycan accommodate at least part of a proximal valve opener in a ready touse position. A nose section of a proximal valve opener can be locatedin the valve cavity.

Infusion or injection hypodermic needles described herein may utilize avalve in a housing having a female Luer connector. For example, thevalve and valve opener of the present disclosure may be placed inside aneedle hub. Also, a needleless valve integrated in a medical device or astandalone needleless valve can utilize the valve described herein.

A needle assembly or a needle device of the present disclosure caninclude a catheter hub with a catheter tube attached to the hub body anda needle hub with a needle extending through the catheter hub and thecatheter tube with the needle tip extending out a distal end or distalopening of the catheter tube in a ready to use position.

Various components described herein can be located in an interior cavityof a catheter hub.

In the ready position, the catheter assembly is ready for use, such asto perform a venipuncture or intravenous access. Sometimes the readyposition first requires removing a protective cap from the catheterassembly or needle assembly. The protective cap can be included forpackaging.

A valve and a valve actuator for use with a catheter hub of the presentdisclosure can also be placed within the needle hub as a second valve.

A needle guard or tip protector, a valve opener or actuator, a valve,and a bushing can be provided with the catheter hub.

Optionally, a needle guard or tip protector comprising a resilientportion can be located outside of a catheter hub, such as in a separatehub different from the catheter hub and needle hub.

A tip protector of the present disclosure may embody any number of priorart guards configured for blocking or covering the needle tip of theneedle.

A tip protector can have a proximal wall and two resilient arms andwherein a change in profile on the needle, such as a crimp or a bulge,can engages a perimeter defining an opening on the proximal wall of thetip protector to retract the tip protector in the proximal direction outof the catheter hub following successful venipuncture. The two arms canintersect or they can run along different sides of the needle and do notintersect along a side view.

When two arms on a needle guard move radially due to axial movement of aneedle, a radial profile, such as shape or dimension, of the needleguard can change. For example, the radial profile of the needle guardcan decrease when the tip of the needle move proximally of two walls topermit the two arms to move in a radial direction.

The needle guard arm or arms can be spread by the needle shaft in aready position and engage the inside of the catheter hub, such as theguard engagement section the catheter hub. The needle guard can berolled or bent to final configuration from a stamped metal sheet.Alternatively, the needle guard can be formed from different components,from all metal components, from plastic components, or combinationsthereof, that are then assembled to form a needle guard.

A valve opener or actuator can comprise a ring or a nose section and atleast one plunger element, such as a leg element or an elongatedextension. The ring can be in contact with the valve in the needleassembly ready to use position. Optionally, the ring can be spaced orslightly spaced form the proximal surface of the valve in the ready touse position.

One or more plunger elements can extend from the ring or nose section inthe proximal direction. In other examples, there can be more than twoplunger elements, such as three or more plunger elements having gapstherebetween. The one or more plunger elements can each be sized andshaped for contact by a male Luer to transfer a distally directed forcefrom the male Luer to the ring or nose section of the valve opener tothen push against a proximally facing surface of the valve to open thevalve, such as to open two or more flaps.

The one or more plunger elements of a valve opener can each have an arcshape or arc cross section along a width. In another example, a plungerelement can be generally flat or planar along a cross section. Thethickness of a plunger element should be sufficiently small or thin sothat a needle guard and two plunger elements have sufficient clearanceto fit within the interior cross-sectional space of a catheter hubwithout being physically binding against the interior of the catheterhub and rendered unmovable or fixed.

In an example, the thickness of a plunger element of a valve opener oractuator and a width of a needle guard are such that no undercut orchannel is required to be formed in the interior wall surfaces of thecatheter hub to accommodate them.

A valve opener of the present disclosure can be made from a metalmaterial, from a plastic material, or from both. When made from a metalmaterial, the valve opener can be formed by deep draw methods and thearc shape cross section of the plunger element can provide addedrigidity when pushed by the male Luer.

Each plunger element of a valve opener can comprise at least twolengthwise edges and a rib can be provided along one or both of thelengthwise edges to further add structural rigidity. One or more gapscan be provided between any two plunger elements. The gaps can provideclearance or space for fluid flow flowing thereacross, such as during IVinfusion. The gap can also be utilized to accommodate a needle guard,such as to act as a holding space.

The ring or nose section of a valve opener can comprises a body with anouter perimeter. The outer perimeter can be generally cylindrical. Theouter perimeter can have a taper. The body can comprise a chamfer and anopening.

The distal edge or intersection of the body between the chamfer and theouter perimeter can have a sharp edge or a blunt edge. In an example,the intersection is a blunt edge comprising a planar surface thatfunctions as an actuation end for pushing against the valve.

The valve opener of the present embodiment can be configured to pushagainst a proximally facing surface of a valve or a multi-part openerfor pushing against both a proximally facing surface of a valve and adistally facing surface of a valve. The valve can have two or more flapsthat can deflect radially and proximally or radially and distally whenactivated.

On the proximal side of a ring or nose section, two plunger elements canbe recessed radially inwardly from an outer perimeter to form or definea shoulder. The outer perimeter of the ring can have an outside diameterof a first dimension and the two plunger elements can define an outsidediameter of a second dimension, which can be smaller than the firstdimension. A shoulder can be provided between the two differentdimensions.

A valve opener can have an inside diameter measured adjacent theintersection or activation end. The inside diameter can change or varyalong a chamfer section of the ring or nose section. The valve openercan further include a minimum inside diameter mID, which can be viewedas the smallest inside diameter of the valve opener.

A needle guard can be located between one or more gaps defined byplunger elements of a valve opener. The plunger elements can eachcomprise an arc-shape cross section. The arc-shape cross section of eachplunger element can be generally C-shaped with the concave portionfacing internally towards the needle guard and the convex portion facingoutwardly away from the needle guard.

The radius of curvature of two C-shaped plunger elements of a valveopener can be different than the radius of a male Luer tip and/or theradius of the interior cavity of the catheter hub. A gap can be providedon each side edge of the proximal wall of the needle guard and theadjacent plunger element.

Two plunger elements of a valve opener can each have an abuttingproximal surface that is sized and shaped to be pushed against by a maleLuer tip or a syringe tip when said tip is inserted into the proximalopening of the catheter hub following successful venipuncture to pushthe valve opener distally against a valve to open the valve. Thearc-shape cross section of each of the two plunger elements can providea sufficiently thick profile to ensure overlapping abutting surfaceswith the male Luer tip and rigidity from buckling.

The C-shaped plunger elements can avoid deflection when pushed by asyringe tip or other male Luer tip, avoid slippage of the syringe tip orLuer tip missing the end surfaces of the plunger elements when thesyringe tip or Luer tip is inserted into the open proximal end of thecatheter hub, and/or avoid a situation in which the syringe tip or Luertip is pushed between the two plunger elements to wedge the two plungerelements between the tip and the interior surface of the catheter hubduring activation of the valve opener.

In some embodiments, the concave portion of the arc-shape cross-sectionof each plunger element can face outwardly, away from the needle guard,while the convex portion of each plunger element faces inwardly towardsthe needle guard.

The ring or nose section of a valve opener can be elastically deformedand then expand when it reaches a recessed hub section of the catheterhub, which can accommodate the ring without deforming the ring.Alternatively, the catheter hub can be designed to expand to allow theassembly of the valve opener. A shoulder can be provided at the recessedhub section, which can form a physical stop for engaging a shoulder onthe valve opener. This can allow the valve opener to be retained withinthe interior cavity of the catheter hub during needle withdrawal andduring use, when the valve opener is pushed distally to activate thevalve and subsequently moves proximally when the male Luer is removed,thus allowing the valve to close.

A valve can have a valve disc comprising a valve body comprising a valvediameter, a valve thickness measured orthogonal to the valve diameter,such as between a proximally facing surface and a distally facingsurface of the valve disc, and one or more slits defining two or moreflaps on the valve disc. Three slits can be provided through the valvethickness to define three flaps. The three slits can originate from apoint and extend radially from about a center point or central portionof the body of the valve, similar to a three-point star, to form threeflaps that can deflect along the slits.

The valve can comprise an outer perimeter that can float inside theinterior cavity of the catheter hub, between a proximal valve opener anda bushing. The outer perimeter of the valve can move proximally anddistally within the interior cavity of the catheter hub and not berestrained by the catheter hub along an axial direction of the catheterassembly. In some examples, the valve can be axially fixed for pushingthereagainst by a proximal valve opener.

The outer perimeter of the valve can be the same or smaller or largerthan the outer perimeter of a ring or nose section of a valve opener. Atleast some part or all of the distal edge, intersection, or activationend of the ring or nose section can be recessed from an outer radialperimeter of the valve so that the distal edge can abut or touch theproximally facing wall surface of the valve. Also, since the valve canfloat, the valve can be positioned inside a single hub body catheter huband can avoid being wedged between a multi-part hub body. However, thevarious components described herein may readily be used with amulti-piece catheter hub without deviating from the scope of the presentdisclosure.

The bushing of the present disclosure can comprise a body comprising afirst body section and a second body section extending from the firstbody section. The second body section can having a cone shape sectionand two or more leg extensions extending from the second body section,such as extending from the cone shape section.

The first body section can have an elongated body that can have acylindrical shape with an optional tapered distal tip or nose section.In some examples, a generally cylindrical ring extends from the secondbody section and the two or more leg extensions extend from thecylindrical ring.

As used herein, the terms first, second, third, etc. are understood todescribe different structures so as to distinguish one from another.However, the terms are not structurally limiting unless the contextindicates otherwise.

One or more gaps can be provided between two adjacent leg extensions.The number of leg extensions incorporated with the bushing can be thesame as the number of flaps incorporated with a valve. The legextensions can be spaced from one another. The leg extensions can beattached to a common structure at a respective fixed end, opposite arespective free end.

The leg extensions on a bushing or the leg extensions of a distal valveopener can define an outside diameter that is smaller than the minimuminside diameter mID of a ring of valve opener. The proximal tip of eachleg extension can have a chamfer or a blunt tip at a proximal end orproximal tip. In one example, a chamfer can be incorporated at theproximal tip of each leg extension and wherein the chamfer can taperinwardly from the exterior of the leg extension.

The bushing can be made from a metal material and the leg extensions canbe unitarily formed with the body. Alternatively, the leg extensions canbe welded to the body of the bushing.

The bushing and the valve can be oriented in the catheter hub so thatthe leg extensions on the bushing are aligned with the flaps on thevalve. This can allow the flaps on the valve to be pushed by the legextensions on the bushing. Thus, if there are three flaps on the valve,the three flaps can be pushed into physical contact with three legextensions on a distal valve opener.

A distally facing wall surface of a valve can touch a leg extension of adistal valve opener and/or a resilient element, such as a spring or anelastic element, or be spaced from the leg extension and/or theresilient element so as to move the valve in a proximal direction.

A distally facing wall surface of a valve can be pushed distally againsta leg extension during use. In some examples, the valve can touch aproximal tip of a leg extension and/or a resilient element in the valveclosed position or be spaced therefrom.

Three leg extensions of a valve opener can be equally spaced along acircumference of a second body section of a bushing. In another example,three leg extensions can be located and spaced in accordance with thepositions of the lugs or flaps on a valve so that when assembled insidea catheter hub, the valve can be pushed distally by a proximal valveopener or valve actuator and the leg extensions on the distal valveopener are aligned to push the lugs or flaps of the valve in theproximal direction to open the valve. The lugs or flaps can be formed byslitting the valve with slits.

During retraction of the needle in the proximal direction followingsuccessful venipuncture, the tip protector can be held axially by theengagement between one or both resilient arms on the tip protector and aguard engagement section on the catheter hub.

The guard engagement section can be a surface discontinuity formed onthe interior surface of the catheter hub. For example, the guardengagement section can comprise a section of a first inside diameter anda section of a second inside diameter, which is larger than the firstinside diameter. The guard engagement section can be annular or circularin shape or can be less than a full circle.

The guard engagement section can embody an internal projection or agroove or a combination of both a groove and a projection formed on theinterior surface of the catheter hub. When a combination of a groove anda projection is used for a guard engagement section to engage a needleguard or tip protector, the groove can be distal to the projection.

Two spaced-apart guard engagement sections can be provided for engagingthe two resilient arms on a tip protector. The two guard engagementsections can be located diametrically opposite of one another at alocation just distal of the section of the female Luer taper of thecatheter hub.

In an example, a valve opener can incorporate a single plunger element.The single plunger element can embody a generally cylindrical bodysection having an interior surface defining a bore having a path orchannel. The cylindrical body section can be located proximally of adistal push end, which can also be annular or circular. A guardengagement section can form on the interior surface of the present valveopener. In other words, the guard engagement segment can be providedwith the interior surface of the valve opener instead of the interiorsurface of the catheter hub. This allows the tip protector or needleguard, such as two resilient arms of the needle guard, to engage thevalve opener in the ready to use position and during retraction of theneedle following successful venipuncture.

The guard engagement section formed on or with the valve opener cancomprise a projection, a recess, an opening, or combinations thereof.

Another aspect of the present disclosure includes a valve openercomprising a nose section with an activation end and two plungerelements extending in a proximal direction of a nose section. A band orring can be provided connecting the two plunger elements together. Theband can be called a stabilizing ring and can connect the two plungerelements together to form a stabilizing structure.

A stabilizing ring can form a continuous perimeter section of a valveactuator that is spaced from another continuous perimeter sectiondefined by a nose section of the valve actuator.

Two stabilizers, which can also be called stabilizer elements, canconnect to two plunger elements to form a stabilizing ring, which canhave a continuous perimeter section.

A valve actuator can have a first continuous perimeter section, asection with one or more reliefs, and a second continuous perimetersection spaced form the first continuous perimeter section.

At the reliefs or through passages of a valve opener, the valve openercan have one plunger element with two lengthwise edges, or two plungerelements each with two lengthwise edges. In some examples, there can bethree or more plunger elements each with two lengthwise edges.

A valve opener can terminate, at its proximal side or end, with astabilizing ring. In another example, one or more plunger element stubsor extensions can extend proximally from the stabilizing ring.

The overall length of a valve opener can be adjusted by adding one ormore plunger element stubs or extensions extending proximally of astabilizing ring.

A first continuous perimeter section can be a nose section of a valveactuator. The nose section can include an activation end for pushingagainst a valve to open the valve. A second continuous perimeter sectioncan be provided and be a stabilizing ring connected to one plungerelement or to two or more plunger elements.

A valve opener provided herein can comprise two plunger elements eachwith two lengthwise edges located between a first continuous perimetersection and a second continuous perimeter section. In some examples, twoplunger element stubs can extend proximally of the second continuousperimeter section.

A valve actuator or opener provided herein can include a single plungerelement extending from a nose section having an activation end andwherein the single plunger element can comprise two or more reliefs orthrough passages formed through the wall of the plunger end. A needleguard or tip protector can engage the edges or perimeters of the reliefsin the ready to use position and during retraction of the needlefollowing successful venipuncture.

When a tip protector engages a perimeter of a valve opener, it isunderstood that the tip protector can engage a section or portion of theperimeter only. For example, when an elbow of a needle guard engages aperimeter of a valve opener, the elbow can contact only a portion or asection of the perimeter. The perimeter can be for a relief or a throughpassage.

Still alternatively, a tip protector can project through the reliefs ofa valve opener but not contact the interior of the catheter hub or theperimeters of the reliefs.

Still alternatively, a tip protector can project through the reliefs ofa valve opener, contacts the interior of the catheter hub, and contactsone or both perimeters of the reliefs.

In a particular example, the part of a tip protector that projectsthrough the reliefs can be one or two elbows of the tip protector.

Alternatively, the tip protector or needle guard can project from aholding space defined by the valve opener through the reliefs to engagethe interior surface of the catheter hub. Bumps, grooves, or recessescan be provided on the interior surface of the catheter hub for theelbows of the needle guard to project through the reliefs from theholding space of the valve projector to engage.

The elbow of each arm of the needle guard may sometimes be referred toas a diagonal section.

The perimeters of two reliefs or through passages can function as guardengagement sections by allowing the elbows of the tip protector toengage thereto. Alternatively, the two elbows of the needle guard canproject through the two reliefs from the holding space defined by thevalve opener to engage the guard engagement sections or segments formedon the interior surface of the catheter hub. Still alternatively, one orboth elbows can be restricted in a proximal direction by a choke pointor choke gap.

In still other examples, at least one elbow of a needle guard or tipprotector can project through a relief or through passage of a valveopener but does not engage the perimeter nor contact the interior of thecatheter hub in a ready to use position. In other examples, two elbowsof a needle guard project through two reliefs or through passages of avalve opener but do not engage the perimeters of the two reliefs orcontact the interior of the catheter hub in a ready to use position.

In some examples, the one or two elbows of a needle guard can contactone or more perimeter of one or more reliefs and/or the interior of thecatheter hub.

Where a valve opener has a single plunger element between a firstcontinuous perimeter section and a stabilizing ring, which can include asecond continuous perimeter section, one or more elbows of a needleguard can be located between the first continuous perimeter section andthe stabilizing ring. If the needle guard has two elbows, both elbowscan be located between the first continuous perimeter section and thesecond continuous perimeter section.

The second continuous perimeter section can represent a proximal mostend of a valve opener. In some examples, one or two plunger elementstubs or extensions can extend proximally of the second continuousperimeter section to extend a length of the valve opener beyond theproximal end of the second continuous perimeter section.

In some examples, the stabilizing ring does not form a continuousperimeter and one or two plunger element stubs or extensions can extendproximally of the non-continuous perimeter section.

The perimeters of the reliefs or the interior surfaces of a catheter hubcan form anchor points for the arms of a tip protector to engage theretoin the ready to use position and during retraction of the needlefollowing successful venipuncture.

The perimeters of the reliefs or through passages of a valve opener canpresent or act as restricting point, choke point, or choke gap for oneor two elbows, respectively, of a needle guard. That is, a dimension ofone elbow measured to a side of a needle can be larger than a dimensionmeasured at an outer perimeter of the valve opener at the relief so thatan interference is provided by the perimeter at the relief againstproximal movement of the needle guard during retraction of the needlefollowing successful venipuncture.

Once an elbow of a needle guard moves radially away from a relief, theradial profile of the needle guard can be reduced and can be smallerthan the inside diameter of the valve opener at the relief. The needleguard can then move proximally of the relief or through passage, such asthrough a stabilizing ring in a proximal direction.

If two elbows are employed by a needle guard, a dimension defined by thetwo elbows can be larger than a perimeter of the valve opener at the tworeliefs so that the perimeters at the two reliefs can act as or providerestricting points or choke points against proximal movement of theneedle guard during retraction of the needle following successfulvenipuncture. Once the two elbows of the needle guard move radially awayfrom the two reliefs of a valve opener, the needle guard can moveproximally of the two reliefs or through passages, such as proximallythrough a bore defined by a stabilizing ring.

In an example, a valve opener can comprise a nose section and a singleplunger element. The single plunger element of the valve opener canembody a generally cylindrical body section having an interior surfacedefining a bore having a path or channel and a proximal perimeter or endedge. A guard engagement section can be formed on the interior surfaceof the valve opener. In other words, the projection, bump or recess canbe formed on the interior wall surface of the valve opener to allowengagement between the needle guard and the interior surface of thevalve opener.

When the present alternative valve opener is used with a needle deviceor catheter assembly, the guard engagement segment can be on thecatheter hub, on the interior wall of the valve opener, or a perimeterof a relief formed through the wall of the valve opener.

There can be one or more reliefs or guard engagement segmentsincorporated with the valve opener.

There can also be one or more guard engagement segments formed with thecatheter hub for use with the one or more reliefs of the valve opener.

The number of guard engagement segments can equal the number of elbowsformed with a needle guard.

Two resilient arms of a tip protector can engage the interior of a valveopener or engage the catheter hub by projecting through reliefs formedthrough the wall of the valve opener.

In yet another example, two openings can be provided through the walllayer of the cylindrical body portion of the valve opener for use withthe guard engagement segment formed with or on the interior of thecatheter hub. The openings each can comprise a perimeter, which can be aclosed perimeter.

In a ready to use position using, a valve opener with two openings orrelief provided through a wall layer of the valve opener, the resilientarm or arms of a tip protector can project through the openings orreliefs to engage a guard engagement segment of the inside of thecatheter hub instead of or in addition to engaging the openings of thevalve opener.

The guard engagement segment can be formed on the interior surface ofthe catheter hub and the proximal cylindrical body section of the valveopener can comprise an opening that surrounds the guard engagementsegment in at least one direction. In an example, when looking radiallyoutwardly away from a needle, the opening on the valve opener cansurround a guard engagement segment formed with a catheter hub.

During retraction of a needle following use, the needle tip can moveproximally of two distal walls, one on each end of a resilient arm, of atip protector or needle guard. The needle guard can instead have onedistal wall and/or one arm. The needle guard can also have two arms butonly one elbow and one distal wall.

A change in profile on a needle, which can be a crimp, a bulge, amaterial build up, or a sleeve, can engage a perimeter of a hole or borethrough a proximal wall of the tip protector. Once engaged, the tipprotector can move proximally with the needle to be removed from thecatheter hub. In a protective position in which the tip protector coversor blocks the needle tip, the valve can remain inside the interiorcavity of the catheter hub. Thus, the valve can be located inside thecatheter hub in both the ready position of the needle and the protectiveposition of the needle.

A male medical implement or instrument can be a male Luer, a syringetip, an IV set connector, or other male tip having a Luer taper, ofcurrent or future ISO standards, and can be inserted into an openproximal end of a catheter hub. The male medical implement can beconnected to an IV tubing, which can be connected to an IV fluid sourcefor fluid delivery through the male medical implement. The male tip canbe understood to be a male Luer tip.

When initially inserting the male medical implement or male tip into theproximal opening of the catheter hub, the male tip can initially contactthe two plunger elements or two plunger element stubs on a valve openerto advance a distally directed force on the two plunger elements or twoplunger element stubs to push an actuation end into a valve to open thevalve. The arc cross section of the plunger elements or plunger elementstubs can have a smaller diameter than the inside diameter of thecatheter hub to provide a larger contact surface for the distal end ofthe male medical instrument.

In some examples, the male tip can abut a proximal ring and can advancethe valve opener against a valve by pushing on the proximal ring, suchas a stabilizing ring.

The distally directed force can move the valve opener in the distaldirection until the geometries of the male tip and the proximal openingof the catheter hub stop further distal advancement of the male tip. Aseal can be provided by the Luer engagement to prevent fluid fromleaking out the proximal opening of the catheter hub.

The ring or nose section of a valve opener can be urged distally andpushes against a proximally facing surface of a valve. The distal edgeof the valve opener can initially push against the proximally facingsurface of the valve. As the valve can be axially movable inside thecatheter hub, the valve can be urged distally by the valve opener, whichcan be urged distally by a male tip. The valve can have a valve disc. Avalve skirt can extend from the valve disc, in the proximal direction,the distal direction, or both the proximal and distal directions.

Due to the presence of leg extensions on a bushing or distal valveopener, the outer edges or outer valve sections of a valve can movedistally while other parts on the valve that abut or contact the legextensions can be stopped from moving distally by the leg extensions. Ineffect, the valve outer edges can move distally while the flaps on thevalve can deflect from a central point or location radially outwardlyand in a proximal direction by the leg extensions on the bushing to opena flow path through the valve.

The chamfer on a ring or nose section and a chamfer on a leg extensioncan facilitate deflection of the flaps on the valve radially outwardlyand in a proximal direction.

Relative diameters defined by a leg extension or a plurality of legextensions and a minimum inside diameter mID of a ring of the valveopener can allow a proximal valve opener and a distal valve opener todeflect the valve therebetween to open the valve. Alternatively, theouter perimeter of the valve can remain in contact with the inside wallof the catheter hub, when pushed distally, with only the flaps openingaround the slit or slits.

Thus, an aspect of the present disclosure is understood to include acatheter assembly comprising a valve comprising one or more slits andtwo or more flaps wherein the valve can comprise parts or sections thatmove in a distal direction and parts or sections that open along aradial direction and in a proximal direction to open a flow path throughthe valve.

In an example, outer edges of a valve can be configured to move distallywhile flaps of the valve can be configured to move radially outwards toopen a flow path through the valve. Also, by incorporating a valve thatcan move in this fashion to open a fluid flow path, the actuationdistance that the valve opener has to travel in the axial direction ofthe catheter assembly to open the valve can be minimized compared to avalve having flaps that only open in a distal direction by a valveopener. Thus, the size of the catheter hub, such as the length of thecatheter hub, can be reduced compared to one that utilizes a valve and avalve opener that opens the valve by deflecting the valve flaps only inthe distal direction. Alternatively, the length or size of the catheterhub can be minimized by overlapping portions along an axial directionbetween a valve opener and a needle guard.

A catheter assembly can comprise a valve and wherein a valve perimetercan float in an axial direction relative to a catheter hub is disclosed.By incorporating a valve with a valve perimeter that can float in theaxial direction, a two-part catheter hub is not required to secure thevalve perimeter therebetween and inside the catheter hub, although atwo-part hub can be used. Therefore, a catheter hub with a singularlyformed hub body may be used with the present catheter assembly. Thus,the size of the catheter hub, such as the outer diameter or dimension ofthe catheter hub, can be reduced compared to one that utilizes atwo-part hub body. The two part hub body where they join along a seamcan thus be reduced to provide a catheter assembly with a relativelysmaller outer profile.

The valve opener can be configured to push the valve against anotherstructure, such as the leg extensions on a bushing or on a distal valveopener. The present valve opener may be viewed as having a multi-piecevalve opening structure. For example, the part with the ring and theplunger elements may be viewed as a proximal valve opener and thebushing with the leg extensions may be viewed as a distal valve opener.The two valve openers can cooperate to open a valve.

A proximal valve opener can be sized and shaped to push against theouter edges or outer periphery of a valve in the distal direction tomove the valve against a distal valve opener. The distal valve openercan be sized and shaped to push a central region or section on the valvein a radially outward direction and part of two or more flaps candeflect in a proximal direction to open a fluid path or flow paththrough the valve.

In an example, the leg extensions on a distal valve opener can beaxially fixed and by pushing the flaps of the valve in a distaldirection against the leg extensions, the flaps can deflect radiallyoutward by the leg extensions on the distal side of the valve. In otherwords, when the valve is actuated to open a flow path through the valve,the valve can be physically pushed by an actuator on a proximal side ofthe valve and an actuator on a distal side of the valve. In a particularembodiment, the valve can be actuated to open a flow path through thevalve by being physically pushed by a ring on a proximal side of thevalve and leg extensions on the distal side of the valve. The distalside can alternatively be pushed by a single leg extension having abore.

The proximal tips of the leg extensions and the distal edge of the ringcan be spaced from a plane drawn orthogonally to the lengthwise axis ofthe catheter assembly. In other words, the proximal tips of the legextensions and the distal edge of the ring can be spaced and not overlapfrom the perspective of this plane and a gap can be provided between thetwo to accommodate the valve therebetween.

The proximal tips of the leg extensions and the distal edge of the ringcan alternatively overlap along an axial direction, which can producethe effect of deflecting the flaps radially outwards a relativelygreater amount than when there is no overlapping. Further, because theflaps can be pushed against axially fixed leg extensions on a bushing,the flaps can deflect backwards in the proximal direction by the legextensions. In yet other examples, the proximal tips of the legextensions and the distal edge of the ring can just touch along a planedrawn orthogonally to the lengthwise axis of the catheter assembly.

A catheter assembly can be provided comprising a valve, a proximal valveopener, a distal valve opener, a needle hub with a needle, and acatheter hub with a catheter tube.

The valve assembly can further include a tip protector for blocking theneedle tip of a needle in a needle protective position.

Following successful venipuncture, a male tip, such as a male Luer, canbe inserted into a proximal opening of the catheter hub to advance theproximal valve opener in a distal direction, which can move the valve ina distal direction against a distal valve opener.

The flaps of a valve can be pivoted in a proximal direction to open afluid path through the valve. The flaps of the valve can deflect in aproximal direction by the leg extensions of the bushing of the presentdevice. The flaps can be deflected in the proximal direction by pushingthe flaps against stationary leg extensions on a distal valve opener.

The flaps on the valve can be deflected in a proximal direction by astructure located distally of the valve and abutting a distally facingsurface of the valve.

The distal valve opener can be a metal bushing having a body with a coneshaped section having two or more leg extensions extending therefrom ina proximal direction. The bushing may also be made from a thermoplasticmaterial.

The biasing or resilient nature of a valve of the present disclosure,which can be made from an elastomer, allows a valve to recoil to itsmore relaxed state when a male tip of a syringe or male medicalimplement is removed from the proximal opening of a catheter hub. Thus,flaps on the valve can recoil by moving distally while the outer edgesor outer sections of the valve body can recoil proximally. This recoilcan push the proximal valve opener in a proximal direction and theshoulder on the proximal valve opener can move towards or against theshoulder inside the interior cavity of the catheter hub.

A coil spring, a leaf spring, or an elastomeric cylinder or element canoptionally be placed between the distal surface of the valve and aninside distal step or shoulder of the catheter hub to facilitate closingthe valve. This spring or elastomeric cylinder, if incorporated, canprovide extra biasing force to return the valve to a closed positionwhen the male medical instrument is removed. The spring or elastomericopener can also push a proximal valve opener in a proximal direction. Ifincorporated, the elastic component, such as the spring or elastomericcylinder, can be spaced from the valve in the ready to use position orcan contact the valve in the ready to use position.

The valve of the present disclosure can be a single use valve or can beopened and closed repeatedly, or at least more than once. The valve maybe open a second time by placing a male tip into the proximal opening ofthe catheter hub and pushing the proximal valve opener in the distaldirection.

Interiorly of a catheter hub, a septum or valve, an actuator or valveopener and a safety clip, such as a needle guard or tip protector, canbe provided. Optionally, the safety clip can be omitted or can be placedoutside the catheter hub, such as a in a third housing. The thirdhousing can be different than the needle hub and the catheter hub.

A flash back plug or blood stopper assembly can be connected to a needlehub to stop blood flow out the flashback chamber of the needle hub. Theflash back plug can be provided at the proximal end the needle hub toallow air to vent but stops blood from spilling out the proximal end ofthe body of the flash back plug, which can include a hydrophobic filter.

A valve having a valve body comprising valve disc and a valve skirtextending in an axial direction from the valve disc can be used withcatheter hubs described herein. In an example, the valve disc cancomprise one or more slits defining one or more flaps to beopened/closed by a valve actuator. The type of slits and flaps and thenumbers of each incorporated with the valve disc can resemble thoseshown and described elsewhere herein.

A valve can comprise a valve body with a valve disc having a proximallyfacing surface and a distally facing surface. Two or more flaps can beincorporated with the valve disc, which can be deflected proximally ordistally.

A valve in accordance with aspects of the present disclosure may be madewith any known elastomer material. In an example, the valve is made froma poly-isoprene material. In other examples, the valve can be made fromany suitable bio-compatible elastic material. Medical grade lubricantsmay be applied to the valve to facilitate valve functionality.

In an embodiment, the valve skirt can be positioned in a recessedsection formed in the interior cavity of the catheter hub, which canprevent the valve from axially moving once situated inside the catheterhub. For example, the valve skirt can be positioned inside a groovedefined by the recessed section and not axially move in both the readyto use position and during activation or actuation of the valve by avalve opener.

The recessed section of the catheter hub can be understood to be a firstrecessed section if the catheter hub incorporates a second recessedsection inside the interior of the catheter hub.

In an example, the recessed section of the catheter hub can have adistal shoulder and a proximal shoulder defining a groove therebetween.The valve skirt of a valve can have a length that is sized and shaped tofit between the proximal shoulder and the distal shoulder. The valveskirt can fit within the groove.

In an example, a valve skirt of a valve can contact the proximalshoulder of a recessed section while a valve disc can contact the distalshoulder of the recessed section.

A valve provided herein can contact a distal shoulder and the proximalshoulder of a recessed section of a catheter hub and be restrainedthereby in a ready to use position and during activation so that thevalve skirt of the valve is axially fixed or not axially movable.

In an example, the outer diameter or exterior surfaced of the skirtsection of a valve forms fit or size-on-size fit with a recessed sectionof the interior of the catheter hub. In other examples, a slightinference fit can be provided between the skirt section and the recessedsection of the catheter hub. In still other examples, a small clearancecan be provided between the exterior surface of the skirt section andthe interior surface of the catheter hub at the recessed section withthe valve skirt in contact with the proximal shoulder and the valve discin contact the distal shoulder of the recessed section.

An outer perimeter of a valve disc can alternatively be considered partof a valve skirt, when a valve skirt is incorporated with a valve disc.

Optionally, there may be no proximal shoulder in a recessed section of acatheter hub since any forces acting on a valve will primarily be in adistal direction.

When a needle is withdrawn following use, there may be some proximallydirected forces on a valve, but these proximally acting forces should below and not enough to move the valve it from its interference fit in thecatheter hub, even without the proximal shoulder.

A distal cavity chamber can be provided distal of a valve disc andproximal of a bushing, which can be used to retain a catheter tube to acatheter hub. In some examples, a helical spring or a resilient biasingelement, such as an elastomeric ring or cylinder, may be provided in thedistal cavity chamber, concentric with the needle, to bias the flaps ofthe valve disc to assist the valve disc to close the one or more slits.The resilient biasing element, if incorporated, can also move a proximalvalve opener in a proximal direction.

In an example, the valve disc can comprise a valve diameter, a valvethickness measured orthogonal to the valve diameter, and one or moreslits defining two or more flaps. A distance between a proximally facingsurface and a distally facing surface can define a valve disc thickness.A valve skirt can extend axially to the lengthwise axis of the valve andcan have an elongated wall that is generally perpendicular to the outerperimeter of the valve disc, forming a generally cylindrical valve body.In some embodiments, the valve skirt may be sloped such that the valveforms a frusto-conical structure.

The valve skirt can have a complex contour, such as having a cylindricalportion connected to a frusto-conical portion.

The skirt can extend either proximally or distally or both proximallyand distally from the valve disc. Thus there can be a proximalcylindrical valve body, a distal cylindrical valve body, or bothproximal and distal cylindrical valve bodies.

The valve skirt can define a valve cavity having an open proximal end.The open proximal end of the valve skirt can be sized to grip anexterior surface of the nose section, can loosely grip the exteriorsurface, or sufficiently large so as to not contact the exterior surfaceof the nose section.

The open proximal end of a valve skirt allows an actuator nose or nosesection of a valve actuator to project therethrough and to advanceaxially within the valve cavity to actuate two or more valve flaps of avalve disc. In one embodiment, at least some part of the actuator noseincluding the distal actuation end of the valve actuator can be locatedinside the valve cavity of the valve prior to actuation by a male Luertip.

The actuator nose of a valve opener can be narrower than the outerperimeter of the valve so that the actuation end of the nose sectionfits within a valve cavity of a valve and abut or touch the valve discin the ready to use position. In some examples, the actuation end can bespaced from the valve disc in a ready to use position.

In an example, the relative dimensions between a valve and an actuatorare such that a nose section of the valve actuator does not touch theinterior wall surface of a skirt section of the valve with some touchingcontemplated.

In an example, the actuation end of a valve actuator contacts aproximally facing surface of a valve disc in a ready to use position andanother part of the valve actuator, such as one or two projections,abuts a shoulder inside the catheter hub to impart a load on the valvedisc in a ready to use position but not enough to open the one or moreslits.

In an example, a proximally facing surface of a valve disc is biased bya valve opener in a ready to use position but the biasing is below athreshold for deflecting one or more flaps on the valve disc. In anexample, one or more projections on an exterior of a valve actuator canabut a shoulder in the catheter hub to cause a distal end section of thevalve opener, such as an activation end, to bias against the proximallyfacing surface of the valve in the ready to use position.

In other examples, the actuation end of a valve actuator can be spacedfrom the proximally facing surface of a valve disc in a ready to useposition and a projection or projections on the valve actuator caneither contact the shoulder or are spaced from the shoulder. When theone or more projections on the valve actuator are spaced from theshoulder of the catheter hub and the actuation end is spaced from thevalve disc, the actuator can float within the catheter hub by a smallamount in the axial direction.

In an example, the valve actuator can comprise a nose section, which canbe elongated in structure and can be generally cylindrical or have adraft angle or taper that terminates in an actuation end. The actuationend can have a blunt distal end surface or can have a sharp edge.

The nose section of a valve opener can have a wall surface with acontinuous circumference, without a notch or a slit, such as a cylinderwith a continuous wall. In some examples, a plurality of spaced apartslits, notches, and/or openings can be provided on the nose section topermit flow or fluid flushing. The nose section of the valve opener candefine a bore. Fluid can flow through the bore. A needle can projectthrough the bore of the nose section in a ready to use position.

Two actuating elements or plunger elements can extend proximally of thenose section. For example, the two plunger elements can be unitarilyformed with the nose section and can extend from the nose section in theproximal direction.

A gap or space can be provided between the two plunger elements forpositioning the needle guard or tip protector therebetween. The gap candefine a holding space. The two plunger elements can each comprise atleast two lengthwise edges and the edges are spaced from one another.

In an example, a projection can extend outwardly from an outer surfaceof one or both plunger elements.

A projection can extend from the outer surface of each plunger element.Each projection can resemble a ramp surface having a generally flat edgefor abutting a shoulder of a recessed section of the catheter hub. Theramp surface of the projection and the direction of the ramp can allowthe valve actuator to be inserted into the interior of the catheter huband be seated within the second recessed section of the catheter hub.

In an example, a transition section of the actuator can extend from anose section of a valve opener and widens axially in the proximaldirection. Two actuating elements can extend from the transitionsection.

Some embodiments may utilize other shapes for the nose section, such ascuboid, rectangular, conical, pyramidal or the like. The nose sectioncan define a bore. Fluid can flow through the bore. A needle can projectthrough the bore of the nose section.

In an example, the actuator or valve opener has a lengthwise axis, theone or more actuating elements can extend axially or parallel to thelengthwise axis. In a particular example, two actuating elements can bediametrically opposed to one another along the lengthwise axis.

In an example, two actuating elements can define an outer diameterhaving a dimension that is larger than a diameter of the nose section.In other examples, the two actuating elements can define an outerdiameter having a dimension that is smaller than a diameter of the nosesection.

In an example, the actuating elements or plunger elements of a valveopener proximal of a nose section can be flexible and deflectable sothat when pushed by a male Luer tip, the actuating elements can deflector flex. The actuating elements can be deflectable by selecting amaterial that has the requisite resilient properties, such ascrystalline thermoplastics.

In other examples, the actuating elements can be deflectable byincorporating one or more weakened sections, such as by incorporating astructurally thin section, by incorporating cut-outs, by employing asmall cross-section compared to other sections of the same elongatedactuating element, or combinations thereof.

Alternatively, the actuating elements can be flexible and deflectable byselecting a material that has the requisite resilient properties and byincorporating one or more weakened sections.

In still other examples, each actuating element can have more than onedifferent cross-sectional profiles or contour along a length section.For example, an elongated plunger element can have a square profilelocated adjacent a crescent-shaped profile.

In an example, the actuating elements can be rigid and not deflectableor deformable when loaded, such as when pushed, by a male Luer tip.Further, stabilizing elements can be incorporated to increase therigidity of the two actuating elements. The two actuating elements mayeach include a cross-sectional profile, at least at a proximal end, thatoverlaps a push end of a male tip so that the male tip can push thevalve actuator into the valve.

The nose section of a valve actuator can be configured to engage thevalve to open the valve disc when an axial force is applied by a maletip to the actuating elements towards the distal end of the catheterassembly, such as during the insertion of an IV Luer adapter.

Generally, the nose section of a valve opener is rigid relative to themore pliable valve, which allows the nose section, and more specificallythe actuation end, to actuate the valve, such as to deflect the one ormore flaps and open the one or more slits on the valve disc. The nosesection may be made of a non-compressible material, such as metal, aplastic, or an elastomer which is harder than the valve material forpushing against and opening the valve.

The illustrated valve actuator embodiment can include a pair of opposedbands or stabilizer elements connecting the two actuating elements at alocation along the length of the actuating elements that are between thenose section and the proximal end of the actuating elements. In someexamples, the stabilizer elements can be located at the proximal end ofthe two actuating elements so that proximal edges of the stabilizerelements are generally flush with the proximal end surfaces of theactuating elements.

In one embodiment, the stabilizer elements, or more generically calledstabilizers, can be arc-shaped, forming an arc following the interiorprofile of the catheter hub and connecting one actuating element toanother actuating element. The stabilizers may form a substantiallycylindrical section on the body of the valve actuator, which body can bespaced apart from the nose section of the valve actuator. In otherwords, the valve actuator can be elongated and can have sections thatare continuous along a radial direction and sections with reliefs orthrough passages that are not continuous along the radial direction.

In an example, the stabilizers can define a continuous body sectionalong a perimeter or radial direction of the valve actuator that isspaced from a continuous body section of the nose section, that is alsocontinuous along a perimeter or radial direction.

The two stabilizers may be joined together with the two plunger elementsto form a ring structure. Optionally, the two stabilizers may beslightly offset and angled from each other. In some embodiments, theremay be one, three, or a different number of actuating elements orstabilizers. In an example, the valve actuator, with the stabilizers andprojections, may be made from plastic, such as by plastic injectionmolding.

The stabilizers can help the valve actuator remain centered within thecatheter hub while the actuator moves, such as when pushed by a maleLuer tip. By staying centered, the nose section can be better alignedwith the valve disc, such as the slits on the valve disc, allowing forsmooth actuation of the valve.

The stabilizers can also provide an engagement, via friction, with theinterior of the catheter hub to prevent the actuator from sliding outthe proximal end of the catheter hub following removal of the male Luertip.

In one embodiment, the nose section of a valve can be configured toremain engaged to the valve disc following actuation of the valve andfollowing removal of the male Luer tip. For example, the nose sectioncan wedge between the one or more slits on the valve disc and be heldthere by friction. Surface features, such as bumps, grooves, or barbs,can be provided with the valve actuator, such as on the nose section, tomaintain the engagement between the actuator and the valve followingactuation and following removal of the male Luer tip.

A relief, opening, or through passage can be provided between atransition section and each of the two stabilizers. The two reliefs orthrough passages can provide clearance so that the interior or centralpart of the valve actuator and the interior surface of the catheter hubcan be in open communication. In other words, between the continuoussection of the nose section and a stabilizing ring, one or two reliefs,through passages, or openings, can be provided. This can improve theflushing characteristics of the device.

The stabilizing ring of a valve actuator, such as the stabilizing ring,can have an inside diameter that is smaller than the diameter defined bythe diagonal dimension of a distal section of two arms of a needle guardwhen the two arms are biased outwardly by the side of the needle shaft.Thus, during installation of the needle guard into the holding space ofthe valve actuator, the needle guard can deflect inside the smallerdiameter to pass through the stabilizing ring and into the open areasdefined by the reliefs.

A valve actuator described herein can include a nose section, atransition section, and two plunger elements extending proximally of thetransition section. The nose section can define a first continuousperimeter section. Other locations of the nose section, away from thefirst continuous perimeter section, can comprise a slit or a slot.

Two stabilizer elements can attach to the two plunger elements on thevalve opener to form a stabilizing ring, which can define a secondcontinuous perimeter section of a valve opener. Each stabilizer elementcan comprise two edges, which can include a first or distal edge and asecond or proximal edge. In an example, the two edges of each stabilizerelement can be parallel to one another.

The two stabilizer elements can instead be skewed or slanted so thatwhile two edges of each stabilizer element or of the same stabilizerelement can be parallel to one another, the two edges from onestabilizer element can be non-parallel to the two edges of the otherstabilizer element. The proximal edges of the two stabilizer elementscan be offset along an axial direction or lengthwise direction of thevalve actuator. The distal edges of the two stabilizer elements can beoffset along an axial direction.

Two reliefs or two through passages can be provided with a valve opener.Each relief can be defined or bounded by a transition section, twoplunger elements, and a respective stabilizer element. The two reliefsor through passages may be referred to as a first relief or firstthrough passage and a second relief or second through passage.

In an example, each relief or through passage can have a perimeter. Eachperimeter can be defined by the structure of the transition section ornose section, two plunger elements, and a respective stabilizer element.As the two stabilizer elements can skew or slant in differentdirections, the two perimeters of the two reliefs or through passages ofthe same valve opener can be different, such as having differentperimeter contours or shapes.

A perimeter of a relief or through passage can have a continuous loop.In other words, a perimeter can be enclosed and not have a slit or aslot to break the continuity of the perimeter. However, where astabilizer element is formed by two stabilizer segments and has a slotor a slit between the two segments, the perimeter of the relief can bean open perimeter or a non-continuous perimeter.

In some examples, two stabilizer elements can extend laterally toconnect to two plunger elements without skewing or slanting in thedistal direction or the proximal direction. When so configured, theedges of the two stabilizer elements can be parallel to one another.Additionally, the four edges of the two stabilizer elements can beparallel to one another and axially offset. That is, the proximal edgeof one stabilizer element can be located more proximally or distallythat the proximal edge of the other stabilizer element while the fouredges are parallel to one another.

The proximal and distal edges of the stabilizer elements can also beother than linear or straight. For example, the two edges can havecurves, undulating surfaces, jagged edges, or combinations thereof.

Two plunger element stubs or extensions can extend proximally of astabilizing ring. Two plunger element stubs can extend from thestabilizing ring and axially align with two plunger elements locateddistally of the stabilizing ring.

In some examples, two plunger element stubs can extend proximally of astabilizing ring and not axially align with the two plunger elementslocated distally of the stabilizing ring. In still other examples, onlyone plunger element stub aligns with one of the two plunger elementslocated distally of the stabilizing ring.

For a valve opener or actuator with only one plunger element between anose section with an activation end and a stabilizing ring, only one ofthe plunger element stubs or none of the plunger element stubs alignswith the one plunger element. There can be two or more plunger elementstubs.

In some examples, there can be more than two plunger element stubs orextensions extending proximally of a stabilizing ring. The two or moreplunger element stubs or extensions can be equally spaced around theproximal periphery of a stabilizing ring or randomly spaced around theproximal periphery of the stabilizing ring.

The plunger element stubs can extend the overall length of a valveactuator.

The number of plunger element stubs and/or the arc-curve of each plungerelement stub, which defines a width of each plunger element stub, canprovide a greater overlapping surface with a male Luer tip than fewernumbers or for a plunger element stub with a relatively smallerarc-curve.

Two plunger elements can each have at least two thicknesses to create aprojection at an interface between the two thicknesses on an outsidesurface of each plunger element. The two projections can be locatedinside a recessed section so that a shoulder at a proximal end of arecessed section inside the catheter hub can provide a stop surface toprevent dislodgement of the valve opener in the proximal direction.

In some examples, only one projection can be employed on one of the twoplunger elements of a valve opener to prevent dislodgement of the valveopener in the proximal direction. In still other examples, each plungerelement can have a single thickness and the projection is formed byadding material to the plunger element during injection molding at thesite of the projection. In still other examples, there can be moreprojections than the number of plunger elements.

In an example, a planar surface section can be provided with the valveactuator on the same side of each stabilizer element. The planar surfacesection can originate from about the nose section or the transitionsection of the valve member and extends proximally to about the locationof the two projections.

Two planar surface sections, one on each side of the valve openercorresponding to the two stabilizer elements, can be provided as a wayto minimize the overall thickness profile of the transition section andof the two plunger elements along a side profile. Thus, in an example, across-sectional dimension of a nose section, of a transition section,and of two plunger elements can be generally constant or be the samewithin typical manufacturing tolerances along a side view.

A holding space can be provided between two plunger elements, inside thestabilizing ring, between two plunger element stubs, or combinationsthereof.

Part or all of a needle guard or tip protector can be located in theholding space in a ready to use position and one or two elbows of thetip protector can project out the relief or the reliefs, if two elbowsare incorporated with the tip protector.

When located in the holding space, a proximal wall of a needle guard canbe flush with the proximal end surface of a plunger element stub,located proximally of the end surface, or located distally of the endsurface. If no plunger element stub is incorporated with the stabilizingring, a proximal wall of a needle guard can be flush with the proximaledge of one or both stabilizer elements, located proximally of theproximal edge of one or both stabilizer elements, or located distally ofthe proximal edge of one or both stabilizer elements.

A distance between two inside surfaces of the two stabilizer elementscan define a choke gap, choke point, or restricting point for a needleguard to limit proximal movement of the needle guard in a ready to useposition and/or during retraction of the needle following intravenousaccess. That is, before a needle tip moves proximally of one or twodistal blocking walls of a needle guard, the choke point or gap canpresent a smaller space for the needle guard to pass proximally of thechoke point or restricting point.

After the needle tip moves proximally of one or two distal blockingwalls of a needle guard, the two distal walls can move radially inwardlyto decrease the needle guard's radial profile, which can be smaller thanthe choke gap. With a smaller radial profile measured at the two elbows,the needle guard can move proximally of the choke point. In an example,the needle guard can move proximally out the holding space and thecatheter hub by a change in profile on the needle abutting a perimeteron a proximal wall of the needle guard and then pulling the needle guardat the proximal wall out the holding space of the valve actuator andcatheter hub.

In an example, when the needle guard's radial profile is decreased, theneedle guard can move proximally of a choke gap or choke point and canmove proximally through a bore defined by a stabilizing ring.

Stabilizer elements on a valve actuator for forming a stabilizing ringcan be non-continuous and each stabilizer element can include a slit orslot.

A stabilizer element on a valve opener can comprise two stabilizersegments spaced from one another by a slit or slot. Each stabilizersegment can be understood to include an inside edge that is spaced fromthe other inside edge of the other stabilizer segment. The two insideedges of the two stabilizer segments can define a slit or a slottherebetween. In addition to an inside edge, each stabilizer segment canalso have two side edges, which can be approximately orthogonal to alengthwise axis of the valve opener. The two stabilizer segments can besimilar or the same or can be different.

When two stabilizer elements are used to form a stabilizing ring, onestabilizer element can be a continuous piece connecting two plungerelements together and the other stabilizer element can benon-continuous, such as being made from two stabilizer segments having aslit or a slot in between. Thus, the stabilizing ring can have a singleslit or slot instead of two or more slits or slots.

The width of the slit or slot can be smaller than the widest width of aneedle guard. The width in this regard can be understood as thedimension that is perpendicular to a lengthwise axis of the needleguard. In some examples, the width of the slit or slot can be smallerthan the width of the distal walls of the needle guard, or the width ofa distal wall if only one distal wall is incorporated. The width of theslit or slot can also be smaller than the width of the needle guard atthe elbow.

The relative dimensions between a slit or slot on a valve opener and thewidth of the needle guard can be selected so that the stabilizing ringscan limit proximal movement of the needle guard, such as limit the twoelbows on the needle guard, from moving proximally of the stabilizingring through the slit or slot during retraction of the needle but beforeactivation of the needle guard. In other words, even with one or moreslits or slots incorporated with the stabilizer elements of a valveopener, the stabilizing ring can still provide restraining surfaces orchoke points to limit proximal movement of a needle guard.

In an example, an elbow of a needle guard cannot slide proximallythrough a slit or slot of a stabilizing ring. In other examples, theslit or slot of a stabilizing ring can have a tapering gap so that whilesome part of a needle guard can slide through the slit or slot, thenarrowing taper of the slit or slot prevents movement of the needleguard completely through the slit or slot.

The valve opener of the present disclosure can incorporate one or twostabilizer elements to form a full loop or less than a full loop, whichcan have gaps or slots when stabilizer segments are used for one or twostabilizer elements. Thus, the one or two stabilizer elements can becontinuous or be segmented with slits or slots between the segments.

A needle guard with one arm and one elbow, two arms but only one elbow,or two arms and two elbows can be used with any of the various valveactuators described herein. The needle guard can be located in a holdingspace of a valve actuator and the one or two elbows can extend at leastpartially through the reliefs or through passages of the valve actuator.

While a stabilizing ring can comprise one or more slits, such as twoslits, the stabilizing ring can provide similar restrictions or chokepoints as a stabilizing ring without any slit or slot.

A stabilizing ring with a non-continuous perimeter section can alsoprovide stability during axial movement of a valve actuator by acting asa bearing to guide the valve actuator against the interior surface of acatheter hub.

Each stabilizer element can comprise two non-continuous edges, which canbe referred to as a distal edge and a proximal edge, or a first edge anda second edge. In an example, the two edges of each stabilizer elementcan be parallel to one another. The two edges from one stabilizerelement can also be parallel to the two edges of the other stabilizerelement in a valve opener with two stabilizer elements.

Two proximal edges of two stabilizer elements can be aligned along anaxial direction or lengthwise direction of the valve actuator. Thedistal edges of the two stabilizer elements can also align along anaxial direction. In other examples, the edges of the two stabilizerelements can be axially offset.

Two reliefs or two through passages can be provided on a valve opener,each defined or bounded by a transition section or nose section, twoplunger elements, and a respective stabilizer element. The two reliefsor through passages may be referred to as a first relief or firstthrough passage and a second relief or second through passage.

In an example, each relief or through passage can have a perimeter. Inan example, each perimeter can be defined by the structure of atransition section or nose section, plunger elements, and a respectivestabilizer element. The two perimeters of the two reliefs or throughpassages can be the same or can have different perimeter contours orshapes. When slits or slots are incorporated, one on each stabilizerelement, the two perimeters of the reliefs are open, such as beingnon-continuous.

The valve opener can be made from a metal material. For example, astamped metal sheet, such as a stamped stainless steel sheet, can becold worked using deep draw methods to form the desired shape. Thevarious openings or gaps of a needle guard can be punched or stamped andthen cold worked to form the desired shaped.

Each plunger element of a valve opener can comprise at least twolengthwise edges and a rib can optionally be provided along one or bothof the lengthwise edges to further add structural rigidity. One or moregaps can be provided between any two plunger elements of a valve opener.The gaps can provide clearance or space for fluid flow flowingthereacross, such as during IV infusion. The gap can also form part of aholding space to accommodate a needle guard.

Two plunger element stubs can extend from a stabilizing ring and axiallyalign with the plunger elements located distally of the stabilizing ringof a valve opener. In other examples, the two plunger element stubs arenot axially aligned with the two plunger elements located distally ofthe stabilizing ring. In still other examples, only one plunger elementstub can be aligned with one of the two plunger elements of the valveopener.

In some examples, a valve opener can terminate at a stabilizing ring andthe valve opener can be without any plunger element stubs. In stillother examples, each plunger element stub located proximally of eachplunger element can be considered part of the same plunger element andthe stabilizer segments are tabs extending radially from the twolengthwise edges of the two plunger elements at a location distal of theproximal end surface of the actuator or valve opener.

In an example, two plunger elements extend from a nose section of avalve opener and a stabilizing ring is located between the nose sectionand proximal most edges of the two plunger elements.

In some examples, there can be more than two plunger element stubs orextensions extending proximally of a stabilizing ring. The two or moreplunger element stubs or extensions can be equally spaced around theproximal periphery of the stabilizing ring or randomly spaced around theproximal periphery of the stabilizing ring.

The plunger element stubs can extend the overall length of a valveactuator. The number of plunger element stubs and/or the arc-curve ofeach plunger element stub, which can define a width of each plungerelement stub, can provide a greater overlapping surface with a male Luertip than fewer numbers of stubs or for a plunger element stub with arelatively smaller arc-curve.

In some examples, the plunger elements stubs can have curved profileswith concave and convex surfaces facing either direction relative to alengthwise axis of the valve actuator. In other words, the convexsurface can face inwards or outwards relative to the lengthwise axis ofthe valve actuator.

Two plunger elements can each comprise a projection on an outsidesurface. The projections can be located inside a recessed section of acatheter hub so that a shoulder at a proximal end of the recessedsection can provide a stop surface to prevent dislodgement of the valveopener in the proximal direction. In some examples, only one projectionis employed on one of the two plunger elements to prevent dislodgementof the valve opener in the proximal direction.

In an example, each projection on a valve opener can be formed bycold-working a surface of the stamped metal sheet at the respectiveplunger element to push out a protruding surface.

The nose section of a valve opener can have a tapered surface extendingin a proximal direction that extends into a transition section. The twoplunger elements can neck down from the transition section with tworadiused sections.

Each plunger element of a valve opener can extend in a proximaldirection from a transition section or from a nose section with agenerally constant width and then necks up with a set of radiusedsections. The necked up sections can transition into two stabilizerelements. The two stabilizer elements can each include two stabilizersegments or each can be formed as a single piece.

Two pair of radiused sections can be located proximally of thestabilizer element or stabilizer segments to form two plunger elementstubs. The plunger elements and the plunger element stubs can both havetwo spaced apart lengthwise edges, which can be provided with ribs toadd strength to the respective structure.

From within a stabilizing ring of a valve actuator and extending in aproximal direction, a plunger element stub can be cold-worked to formoutwardly bulging portions relative to the lengthwise axis of the valveopener to form curved surfaces along the cross-section of the plungerelement stub. The bulging portions can alternatively be formed inwardlyto form inward bulging portions. The bulging portions can be included toform the concave and convex surfaces for the plunger element stub, orstubs if more than one is incorporated, to strengthen the structures ofthe stub or stubs.

A distance between two inside surfaces of the two stabilizer elements ofa valve opener can define a restricting point, a choke gap or a chokepoint for a needle guard to limit proximal movement of the needle guardin a ready to use position and/or during retraction of the needlefollowing intravenous access. That is, before the needle tip movesproximally of one or two distal blocking walls of a needle guard, thechoke point or gap can be sized sufficiently small to prevent the needleguard from passing proximally of the choke point. However, after theneedle tip moves proximally of one or two distal blocking walls of theneedle guard, the two distal walls can move radially inwardly todecrease the needle guard's radial profile, which can be smaller thanthe choke point. With a smaller radial profile after the arm or arms ofthe needle guard are actuated, the needle guard can move proximally ofthe choke point.

In an example, a needle guard can have a distal portion that is largerthan a choke point and wherein the distal portion of the needle guardcan transition to have a relatively smaller profile and be smaller thanthe choke point. In an example, the distal portion of the needle guardis the location between two elbows of the needle guard.

When the tip protector is positioned between the two plunger elements,the two distal walls of the needle guard, more specifically the twosections with the diagonal dimension, can be located in the reliefs toengage the guard engagement surface on the interior surface of thecatheter hub. This allows the needle guard to project from the holdingspace of the valve actuator through the two reliefs to engage with theguard engagement surface of the catheter hub or the perimeters of thetwo reliefs.

A second undercut or recessed section proximal of the first recessedsection can be provided in the interior cavity of the catheter hub foraccommodating the two sections with the diagonal dimension of the needleguard.

The needle guard can be prevented from sliding in the proximal directionduring retraction of the needle following successful venipuncture by ashoulder of a recessed section or by some other surface feature on theinterior of the catheter hub, such as a guard engagement surface on theinterior of the catheter hub.

Optionally or alternatively, the distal edge of one or both stabilizerscan provide the restraining surface to prevent the needle guard fromearly activation during retraction of the needle, prior to the needletip moving proximally of the two distal walls. In addition to the distaledge, the stabilizers can also have a proximal edge.

The valve opener can be made from a metal material or from a plasticmaterial. When made from a metal material, the valve opener can beformed by deep draw or bending methods and the arc shape cross sectionof the actuating element can provide added rigidity when pushed by themale Luer.

Each actuating element can comprise at least two lengthwise edges and arib can be provided along one or both of the lengthwise edges to furtheradd structural rigidity. One or more gaps can be provided between anytwo actuating elements. The gaps can provide clearance or space forfluid flow flowing thereacross, such as during flushing blood or IVinfusion. The gap between the actuating elements can define a holdingspace to accommodate a tip protector.

In some embodiments, a majority or most if not all of the tip protectorcan fit within a holding space formed by a body of the valve actuator,between two plunger elements, in a ready to use position. This can allowthe catheter hub to be more compact, as less longitudinal space isneeded within the hub to fit both the actuator and the tip protectorserially lengthwise or when the two only partially overlap in the axialdirection.

The tip protector can fit completely within the holding space of theactuator to further reduce the needed space or length in the catheterhub. The proximal wall of the needle guard can be generally flush oreven with the proximal end surfaces of the two plunger elements in aready to use position. To accommodate this nesting between the needleguard and the valve actuator, reliefs can be provided with the valveactuator so that one or two elbows on the needle guard can project outfrom within a holding space of the valve actuator.

A relief or through passage allows a tip protector to engage with theinterior of a catheter hub. Alternatively, the relief or through passageallows the tip protector to simply project out from a holding space, andcontact or be spaced from a perimeter of the relief. Proximal to therelief, a stabilizer can provide additional rigidity and/or a greaterengagement surface for the catheter hub.

When a tip protector only engages with the perimeter of a relief orthrough passage, such as the distal edge of the relief of an actuator,then no deformity or change of diameter is required on the inside wallof the catheter hub and the tip protector can still be placed in thefemale Luer taper section while complying with the international Luerstandard for conical fittings, for current and future internationalstandards.

Optionally, one or more grooves or recessed sections can be incorporatedoutside of the Luer taper of a catheter hub to accommodate any of thevarious components discussed herein. For example, one or more groovescan be provided distal of the Luer taper section of the catheter hub toengage a project, shoulder, elbow, or any of the various structures andcomponents discussed elsewhere herein.

The actuating elements or plunger elements of a valve actuator canextend past the proximal edge of one or more stabilizer elements tosubstantially the same distance as the proximal wall of the tipprotector. In an illustrated embodiment, the tip protector substantiallycan fit within the holding space of the actuator and the proximal wallof the tip protector is approximately even with the proximal ends of theactuating elements, in the axial direction.

In a valve actuator retracted position in which the actuator is notadvanced by a male tip to open a valve, the actuation end of the nosesection of the actuator can be spaced or not pushed into the valve andopening the one or more slits of the valve. This position can also bethe valve pre-activated position. That is, the valve actuator retractedposition can be the position in which the actuation end is not pushedinto the valve to open the slits of the valve, whether before the firstactivation of the valve or after activation and the male Luer tip hasbeen removed following advancement of the actuator.

Advancing the actuator in a distal direction can cause the actuation endof the actuator to advance against a valve disc and deflect the flapsradially and distally to open a fluid path to be formed through thecatheter assembly.

When initially inserting a male medical implement, such as a male Luertip, into the proximal opening of a catheter hub, the male tip caninitially contact the actuating or plunger elements, plunger elementstubs, or stabilizer ring on the actuator to advance a distally directedforce on the actuator to open the valve. The distally directed force canmove the actuator in the distal direction until the geometries of themale tip and the proximal opening of the catheter hub stop furtherdistal advancement of the male tip.

In an example, a female Luer taper of the catheter hub and a male Luertaper of the male tip can mate and block distal advancement of the maletip further into the opening of the catheter hub. A seal is provided bythe Luer engagement to prevent fluid from leaking out the proximalopening of the catheter hub when the two components mate or register.

As the actuator moves distally by the distal advancement of a male tip,the nose of the valve actuator can be urged distally and pushes againstthe proximally facing surface of a valve disc. In particular, the noseof the actuator can initially push against the proximally facing surfaceof the valve disc and since the valve can be axially fixed within arecessed section of a catheter hub, the one or more flaps on the valvedisc can deflect radially and in the distal direction. Fluid from themale tip can then flow through the catheter hub, through the valve, andthrough the lumen of the catheter tube. A valve skirt can be providedextending in an axial direction from the valve disc.

Alternatively, a suction can be applied by a male medical instrument,such as a syringe or vacuum blood collection tube, and blood aspiratedfrom the patient in a proximal direction through an opened valve. Thiscan often be done for testing samples before infusion therapy iscommenced. Also, typically any remaining blood can first be flushed fromthe inside of the catheter hub before infusion therapy is commenced.

Even after removal of a male tip following actuation, a valve actuatorcan remain engaged to hold the valve open. That is, the friction betweenthe valve actuator and the valve disc can exceed the restoring forcesproduced by the valve in attempting to return to its un-deformedposition. This activated position can be considered a one-time use orone-time actuation since the valve actuator and valve do not return tothe pre-activation position when the male tip is removed.

In an alternative embodiment, the nose section of an actuator can beconfigured so that when pushed into the valve during activation, theactuation or activation end does not extend distally past the flaps ofthe valve disc. This configuration can be employed so that the valveactuator is pushed by the flaps when the male Luer implement is removedto return to its pre-activated position. A conical configuration at thedistal end of the actuator can be such a configuration, which canmaintain a proximally directed force vector, which is greater than aperpendicular force vector. The angle of the cone can be designed toprovide the necessary force vectors when the actuator has reached itmaximum distal movement and its minimum distal movement. The differencebetween the maximum movement and minimum movement of a standard Luerconnector is approximately 2.5 millimeters. Thus, internationalstandards for Luer fittings can be consulted with when sizing a tip ofan actuator.

Additionally, a spring or an elastic element or ring, can beincorporated at a distal cavity chamber of the catheter hub to increasethe re-coil or returning forces of the valve to facilitate pushing thevalve actuator in the proximal direction following removal of the maletip to return to the actuator to the pre-activated position. The biasingelement, which can be a spring or an elastic element, can also help toclose the flaps of the valve disc and return the valve to the valveclosed position. In this manner, the valve and valve actuator can bere-closed after the initial activation and re-open and so forth,repeatedly. Alternatively, the flaps can be made thicker to provideenough restoring forces without the need for an elastic element. Stillalternatively, the flaps can be thicker and a biasing element is used toprovide the restoring forces on the valve and the valve actuator.

The distal edge and the proximal edge on a stabilizer or a stabilizerelement can be non-parallel to the proximal edge of the plunger elementsor plunger element stubs, the latter if incorporated. The distal edgeand the proximal edge of an upper or first stabilizer can be parallel toeach other and the distal edge and the proximal edge of a lower orsecond stabilizer can be parallel to each other but the correspondingedges of the upper and lower stabilizers do not have to be parallel toone another. Said differently, the upper stabilizer can have a distaltilt while the lower stabilizer can have a proximal tilt.

An actuator can comprise a generally cylindrical nose section or cancomprise a conical frustum shape nose or a combination of bothcylindrical and conical shape sections and an activation end at a distalend thereof. Actuating arms or plunger elements can extend lengthwisefrom the nose section. Stabilizer elements can be incorporated and thestabilizer elements can have edges that are generally even withoutoff-setting edges. In a ready to use position of a needle assembly orcatheter assembly, the nose section may be in contact with a valve discof a valve or can be slightly spaced from the proximally facing surfaceof the valve disc. The valve can further include a valve skirt having avalve cavity and the nose section, or at least the activation end of thenose section, located within the valve cavity.

A relief or through passage in the wall of a valve actuator can provideaccess for a tip protector to engage with the interior of the catheterhub or to otherwise be retained inside the catheter hub, as previouslydescribed. In one embodiment, two through passages or reliefs onopposite sides of the body of the actuator can be provided to giveaccess to the interior of the catheter hub to two arms of a tipprotector. Other embodiments have different number of through passagesor reliefs, such as one, three or more. For example, there may be onerelief or through passage in a cylindrical actuating element.

Most of the tip protector can be fitted inside a holding space of avalve actuator with only a portion of the tip protector extending in aproximal direction past the proximal end of the actuator. For example,the proximal wall and part of the two arms of the tip protector canextend proximally of the proximal end of the actuator.

One or more ribs or projections can be formed on the exterior surfacesof the actuating arms or plunger elements of an actuator to engage witha shoulder in a recessed section of a catheter hub to retain the valveactuator inside the catheter hub in the ready to use position and usedposition.

An interior of a catheter hub can comprise one, two, or more grooves.Each groove can comprise a recessed section formed into the wall of thecatheter hub. Each recessed section can comprise a shoulder. A firstgroove, if incorporated, can be used to retain a valve. A second groove,if incorporated, can be used to engage one or more projections on avalve actuator to limit proximal movement of the valve actuator. A thirdgroove, if incorporated, can be used to engage a tip protector.Additional grooves can be incorporated.

A valve can have one or more ridges, such as an engagement surface,formed on the outer surface of the valve skirt. Micro-channels can beprovided on an exterior of a valve for air venting between the valve andthe interior surface of a catheter hub. Medical grade lubricants can beapplied on the valve to facilitate movement.

An engagement surface on a valve can comprise a projection or a grooveor a combination of both a groove and a projection formed on an exteriorsurface of the valve. For example, the engagement surface may compriseof a section having a first outer diameter (e.g., peak/projection) and asecond outer diameter (e.g., valley/groove), with the sections repeatedone or more times on the outer perimeter of the valve. In anotherexample, the grooves and/or projections may be formed as a singlecontinuous, spiral structure on the exterior of the valve.

In some embodiments, the engagement surface on a valve can extendcircumferentially along the outer surface of the valve, forming rings ora spiral thread. In other embodiments, the engagement surface cancomprise several separate sections formed on the outer surface, such asseparate protrusions/recesses or the thread sections on an interruptedscrew.

A catheter hub may be provided with a corresponding engagement surfaceon the interior surface of the catheter hub to mate with the engagementsurface of the valve. The engagement surface of the catheter hub can besimilar to the engagement surface of the valve, but with inversefeatures in order to mate with the valve engagement surface.

By forming engagement surfaces on the valve and the catheter hub, thevalve can be better retained in the correct position in the catheterhub, even as a valve actuator applies force to the valve. The valve,with the engagement surface and the corresponding surface inside thecatheter hub, can be axially fixed within the catheter hub without arecessed section having proximal and distal shoulders.

Two engagement arms can be formed on the proximal end of a valve,extending radially inwards from the interior surface of a valve skirt.The engagement arms can be configured to mate with the engagementshoulders formed on a valve actuator. The two engagement arms on thevalve can be configured to engage with the two engagement shouldersformed by two reliefs of a valve actuator. In other embodiments,different numbers of engagement shoulders and engagement arms may beused (e.g., one, three, or more).

In a ready position, a nose of an actuator can lie within a holdingspace of a valve, adjacent to the proximally facing surface of a valvedisc of the valve. The valve skirt can surround the nose with theengagement arms on the valve partially extending into the reliefs orthrough passages of the actuator and engaging with the engagementshoulders. In one embodiment, the engagement arms can have asufficiently low profile to not interfere with the needle and the tipprotector, such that the arms do not interfere with the movement of theneedle and the tip protector.

Aspects of the present disclosure can include a needle assemblycomprising a needle hub with a needle having a needle tip extending froma distal end of the needle hub a catheter tube attached to a catheterhub having a body comprising an interior wall surface defining aninterior cavity, the needle extending through the catheter tube and theneedle tip out a distal end of the catheter tube in a ready to useposition; a valve positioned in the interior cavity of the catheter hub,said valve comprising an outer perimeter, at least one slit and two ormore flaps; a valve opener sized and shaped to open the at least oneslit to open the valve, said valve opener comprising a nose sectionhaving an activation end and a continuous perimeter section, two plungerelements each having two lengthwise edges, two stabilizer elementsconnecting the two plunger elements to form a stabilizing ringcomprising a continuous perimeter section, a holding space, and twothrough passages located between the nose section and the stabilizingring; a needle guard comprising two resilient arms located at least inpart inside the holding space, wherein said needle guard comprises twoelbows projecting through the two through passages and in contact with aperimeter of each through passage or the interior wall surface of thecatheter hub.

The needle guard can be located at least in part inside a holding spaceof a valve opener so that an elbow or diagonal section on an arm of theneedle guard extends through one of the through passages of the valveopener. The elbow or diagonal section of the needle guard can be incontact with a perimeter of the through passage, spaced from theperimeter of the through passage, in contact with the interior surfaceof the catheter hub, spaced from the interior surface of the catheterhub, or a combination of contacting the perimeter of the through passageand the interior surface of the catheter hub.

A still further aspect of the present disclosure can include a needleguard comprising a resilient arm located at least in part inside aholding space of a valve opener, wherein said needle guard can comprisean elbow projecting through a first through passage, projecting throughthe first through passage and in contact with a perimeter of the firstthrough passage, projecting through the first through passage and incontact with an interior surface of a catheter hub, or a combination ofprojecting through the first through passage and in contact with theperimeter of the first through passage and the interior surface of thecatheter hub.

The elbow or diagonal section can be a first elbow and the needle guardcan include a second elbow and wherein the second elbow can extendthrough the other one of the through passages of the valve opener, whichcan be called a second through passage. The second elbow or diagonalsection of the needle guard can be in contact with a perimeter of thesecond through passage, spaced from the perimeter of the second throughpassage, in contact with the interior surface of the catheter hub,spaced from the interior surface of the catheter hub, or a combinationof contacting the perimeter of the second through passage and theinterior surface of the catheter hub.

In some examples, a valve actuator or opener can have only one throughpassage and a needle guard can comprise a resilient arm located at leastin part inside the holding space of the valve opener, wherein saidneedle guard comprises an elbow projecting through the only one throughpassage, projecting through the only one through passage and in contactwith a perimeter of the only one through passage, projecting through theonly one through passage and in contact with the interior surface of thecatheter hub, or a combination of projecting through the only onethrough passage and in contact with the perimeter of the only onethrough passage and the interior surface of the catheter hub.

The valve can comprise a valve disc and a valve skirt extending in aproximal direction and defining a valve cavity. The valve can optionallyinclude a valve skirt extending in a distal direction of the valve disc.

The activation end of the valve opener can be located in the valvecavity of the valve in the ready to use position.

The activation end can be in contact with a proximally facing surface ofthe valve disc in the ready to use position.

The valve opener can comprise a projection extending radially of alengthwise axis of the valve opener and wherein the projection cancontact a shoulder on the interior surface of the catheter hub in theready to use position.

The valve opener can contact both the valve disc and the shoulder at thesame time in the ready to use position.

The projection can extend radially of a plunger element on the valveopener. The projection can have a ramped surface with a straight edge.

The projection can be considered a first projection and wherein thevalve opener can comprise a second projection from the first projectionand wherein the activation end can apply a load on the valve disc butnot open the at least one slit.

A bushing can wedge a proximal end of the catheter tube against theinterior surface of the catheter hub.

A resilient element can be located inside the catheter hub between thebushing and the valve disc, and wherein the resilient element can besized and shaped to push the two or more flaps of the valve in aproximal direction.

The resilient element can be an elastic element an elastic cylinder, ahelical spring, or a leaf spring. The helical spring can comprise aplurality of interconnected coils.

A further aspect of the present disclosure can include a method ofassembling a needle assembly. The method can comprise the steps:providing a catheter hub with a catheter tube having an open distal endand a proximal end attached to the catheter hub by a bushing, saidcatheter hub comprising a hub body having an interior surface definingan interior cavity and a proximal opening; positioning a valvecomprising at least one slit and two or more flaps proximal of thebushing; positioning a valve opener proximal of the valve and inside theinterior cavity of the catheter hub to slidably push open the valve whenactuated by a male medical implement, said valve opener comprising anose section having an activation end and a continuous perimetersection, two plunger elements each having two lengthwise edges, twostabilizer elements connecting the two plunger elements to form astabilizing ring comprising a continuous perimeter section, a holdingspace, and two through passages located between the nose section and thestabilizing ring; placing a needle, which is attached to a needle hub,through the catheter hub, the valve, and the catheter tube so that a tipof the needle extends out a distal opening of the catheter tube in aready to use position; and placing a needle guard at least in partinside the holding space of the valve opener so that an elbow on each oftwo arms of the needle guard extend through the two through passages ofthe valve opener.

In some examples, the placing of the needle guard can comprise placingthe needle guard at least in part inside a holding space of a valveopener so that an elbow or diagonal section on an arm of the needleguard extends through one of the through passages of the valve opener.The elbow or diagonal section can be in contact with a perimeter of thethrough passage, spaced from the perimeter of the through passage, incontact with the interior surface of the catheter hub, spaced from theinterior surface of the catheter hub, or a combination of contacting theperimeter of the through passage and the interior surface of thecatheter hub.

The needle guard can comprise a second elbow or diagonal sectionextending through the other of the two through passages. The secondelbow or diagonal section can project through the other of the throughpassages in similar manner as the elbow or diagonal section, which canbe a first elbow.

The needle guard can comprise a proximal wall and a perimeter definingan opening on the proximal wall, and wherein the two arms extenddistally of the proximal wall. The needle guard can be located entirelywithin the interior of the catheter hub.

The needle guard can be located entirely within the interior of thecatheter hub with a proximal end of the needle guard located even with aproximal end surface of the valve opener or located proximally of theproximal end surface of the valve opener or the proximal end surface ofthe needle guard can be located distal of the proximal end surface ofthe valve opener.

The valve can comprise a valve disc and a valve skirt extending in aproximal direction and defining a valve cavity and wherein theactivation end of the valve opener can be located in the valve cavity inthe ready to use position.

The activation end of the valve opener can be in contact with aproximally facing surface of the valve disc in the ready to use positionand wherein two spaced apart projections on the valve opener abut ashoulder in a recessed section of the catheter hub.

The two stabilizer elements can each comprise two parallel edges.Methods of making and of using the catheter assemblies and theircomponents described elsewhere herein are within the scope of thepresent disclosure.

Aspects of the present disclosure can include a needle assemblycomprising: a needle hub with a needle having a needle tip extendingfrom a distal end of the needle hub; a catheter tube attached to acatheter hub having a body comprising an interior surface defining aninterior cavity, the needle extending through the catheter tube and theneedle tip out a distal end of the catheter tube in a ready to useposition.

The needle assembly can further comprise a valve positioned in theinterior cavity of the catheter hub, said valve comprising an outerperimeter, at least one slit, and two or more flaps.

The needle assembly can further comprise a valve opener sized and shapedto open the at least one slit to open the valve, said valve opener cancomprise a nose section having an activation end and a continuousperimeter section, two plunger elements each having two lengthwiseedges, two stabilizer elements connecting the two plunger elements toform a stabilizing ring comprising a continuous perimeter section, aholding space, a first through passage and a second through passagelocated between the nose section and the stabilizing ring.

The valve opener can comprise a nose section having an activation endand a continuous perimeter section, a plunger element having twolengthwise edges, a stabilizing ring comprising a continuous perimetersection at an end of the plunger element, a holding space, and a throughpassage located between the nose section and the stabilizing ring.

The holding space can be located between two plunger elements or insidea stabilizing ring.

The stabilizing ring can define a continuous perimeter section or caninclude one or more slits, such as a ring that is non-continuous.

The terms first, second, third, and so forth are understood to designatenames to distinguish different elements, structures, or components fromone another but not necessarily structurally limiting unless the contextindicates otherwise. For example, a first arm and a second arm are twodifferent arms, which may or may not have the same structure unless oras modified by further limitations.

The needle assembly can further comprise a needle guard comprising aresilient arm located at least in part inside the holding space of thevalve opener, wherein said needle guard can comprise an elbow projectingthrough the first through passage and in contact with a perimeter of thethrough passage, the interior surface of the catheter hub, or both theperimeter of the through passage and the interior surface of thecatheter hub.

A method of assembling a needle assembly can comprise: providing acatheter hub with a catheter tube having an open distal end and aproximal end attached to the catheter hub by a bushing, said catheterhub comprising a hub body having an interior surface defining aninterior cavity and a proximal opening.

The method can further comprise positioning a valve comprising at leastone slit and two or more flaps proximal of the bushing; positioning avalve opener proximal of the valve and inside the interior cavity of thecatheter hub to slidably push open the valve when actuated by a malemedical implement.

The valve opener usable with the method of the present disclosure cancomprise a nose section having an activation end and a continuousperimeter section, two plunger elements each having two lengthwiseedges, two stabilizer elements connecting the two plunger elements toform a stabilizing ring comprising a continuous perimeter section, aholding space, and two through passages located between the nose sectionand the stabilizing ring.

Two plunger element extensions can extend proximally of the stabilizingring.

The valve opener usable with the method of the present disclosure cancomprise a nose section having an activation end and a continuousperimeter section, a plunger element having two lengthwise edges, astabilizing ring comprising a continuous perimeter section at an end ofthe plunger element, a holding space, and a through passage locatedbetween the nose section and the stabilizing ring.

The method can further comprise placing a needle, which is attached to aneedle hub, through the catheter hub, the valve, and the catheter tubeso that a tip of the needle extends out the open distal end of thecatheter tube in a ready to use position; and placing a needle guard atleast in part inside the holding space of the valve opener so that anelbow or diagonal section on an arm of the needle guard extends throughone of the two through passages of the valve opener and in contact witha perimeter of the through passage, the interior surface of the catheterhub, or both the perimeter of the through passage and the interiorsurface of the catheter hub.

A still further aspect of the present disclosure can include a catheterassembly comprising a needle hub with a needle having a needle tip; acatheter tube attached to a catheter hub having a body comprising aninterior surface defining an interior cavity, the needle extendingthrough the catheter tube; a valve positioned in the interior cavity ofthe catheter hub, said valve comprising at least one slit and two ormore flaps; a valve opener comprising a nose section having anactivation end, at least one plunger element having a proximal endsurface for pushing by a male medical implement; a needle guardcomprising a resilient arm extending in a distal direction of a proximalwall comprising a perimeter defining an opening, the needle tip isconfigured for blocking the needle tip.

Methods of use, of making, and/or of assembling catheter assemblies andneedle assemblies and components thereof as described herein are withinthe scope of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present device, system,and method will become appreciated as the same becomes better understoodwith reference to the specification, claims and appended drawingswherein:

FIG. 1 is a schematic cross-sectional side view of a catheter assemblyin a ready position in which the needle tip extends out a distal end ofa catheter tube.

FIG. 2 is a schematic cross-sectional side view of the catheter assemblyof FIG. 1 in a transition position or state in which the needle is inthe process of being removed from the catheter tube and the catheterhub, such as following successful venipuncture.

FIG. 3 is a schematic cross-sectional side view of the catheter assemblyof FIG. 1 in which the needle has completely separated from the catheterhub and the needle tip is covered by a needle guard.

FIG. 4 is a schematic cross-sectional side view of the catheter assemblyof FIG. 1 in which the catheter hub is now connected with a male Luerand the proximal valve actuator advanced by the male Luer to push thevalve into a distal valve actuator to open the valve.

FIGS. 5A and 5B show an end view and a cross-sectional side view,respectively, of a proximal valve actuator in accordance with aspects ofthe present disclosure.

FIG. 5C shows a cross-section end view taken along line 5C-5C of FIG. 1,which shows the needle guard and inwardly arc-shaped plunger elements ofthe proximal valve opener.

FIG. 5D is an alternative embodiment of the valve opener of FIG. 5C,showing outwardly arc-shaped plunger elements.

FIG. 5E shows an alternative embodiment of the valve opener of FIG. 5B,wherein the proximal section is a cylinder for surrounding at least partof a needle guard.

FIGS. 6A and 6B show an end view and a cross-sectional side view,respectively, of a distal valve actuator in accordance with aspects ofthe present disclosure.

FIGS. 6C and 6D show an end view and a cross-sectional side view,respectively, of an alternative distal valve actuator having threefingers or plunger elements for use with a valve having three lugs.

FIG. 7 is an isometric view of the needle guard of FIG. 1.

FIG. 8A is a front view of an exemplary single slit disk valve.

FIG. 8B is a front view of an exemplary three slit disk valve.

FIG. 8C is a front view of a single slit disk valve with v shaped slitsat each end of the single slit.

FIG. 9 is an exploded perspective of a needle assembly in accordancewith further aspects of the present disclosure.

FIG. 9A is an isometric cut-away view of the needle assembly of FIG. 9in an assembled state.

FIG. 9B is an isometric view of the needle assembly of FIG. 9.

FIGS. 10A and 10B show partial cross-sectional side views of the needleassembly of FIG. 9 in an assembled state and along different viewingplanes.

FIG. 11 shows a partial perspective cut-away view of the needle assemblyof FIG. 9 is an assembled state.

FIG. 12A shows a partial cross-sectional side view of the needleassembly of FIG. 9 after removal of a needle.

FIG. 12B shows a partial cross-sectional side view of the needleassembly of FIG. 12A with the valve opener advanced distally against avalve to open the valve.

FIG. 13A is a perspective view of a valve opener provided in accordancewith further aspects of the present disclosure.

FIGS. 13B and 13C show different views of the valve opener of FIG. 13Awith a needle guard located in a holding space of the valve opener.

FIG. 14A shows a valve with a valve disc and a valve skirt in accordancewith further aspects of the present disclosure.

FIG. 14B is a partial side cut-away view of a needle assembly with thevalve of FIG. 14A located inside the interior of a catheter hub.

FIG. 14C is a partial perspective cut-away view of the needle assemblyof FIG. 14B.

FIGS. 15A-15C depict a valve opener of the present disclosure.

FIG. 16-16C depict another valve opener of the present disclosure.

DETAILED DESCRIPTION

The detailed description set forth below in connection with the appendeddrawings is intended as a description of the presently preferredembodiments of catheter assemblies with control valves provided inaccordance with aspects of the present devices, systems, and methods andis not intended to represent the only forms in which the presentdevices, systems, and methods may be constructed or utilized. Thedescription sets forth the features and the steps for constructing andusing the embodiments of the present devices, systems, and methods inconnection with the illustrated embodiments. It is to be understood,however, that the same or equivalent functions and structures may beaccomplished by different embodiments that are also intended to beencompassed within the spirit and scope of the present disclosure. Asdenoted elsewhere herein, like element numbers are intended to indicatelike or similar elements or features.

With reference now to FIG. 1, a catheter assembly 100, which may morebroadly be referred to as a needle assembly or a needle device, is showncomprising a catheter hub 102 with a catheter tube 104 attached to thehub body 50 and a needle hub 106 with a needle 108 extending through thecatheter hub 102 and the catheter tube 104 with the needle tip 110extending out a distal end or distal opening 112 of the catheter tube ina ready to use position. In the ready position, the catheter assembly100 is ready for use, such as to perform a venipuncture or intravenousaccess. Sometimes the ready position first requires removing aprotective cap (not shown) from the catheter assembly or needle assembly100.

A flash back plug 114 can be provided at the proximal end 118 of theneedle hub 106, which allows air to vent but stops blood from spillingout the proximal end 118 when entering the flashback chamber 116 duringprimary flashback. Alternatively, a syringe can be attached to theproximal end of the needle hub. The valve and actuator described furtherbelow can also be placed within the needle hub as a second valve. Theneedle hub 106 further comprises a shoulder 120 or other surfaces thatphysically contact the catheter hub 102, such as the proximal endsurface 122 of the catheter hub, to axially register the two hubs 102,106 to set the length of the needle tip 110 projecting out of the distalopening 112 of the catheter tube 104.

Interiorly of the catheter hub 102, in the interior cavity 130, a needleguard or tip protector 132, a valve opener or actuator 134, a valve 136,and a bushing 138 are provided. The proximal opening of the catheter hub102 can be sized with a female Luer taper. The bushing 138 is configuredto wedge the proximal end of the catheter tube 104 against the interiorwall surfaces of the catheter hub 102 to retain the catheter tube 104 tothe catheter hub 102.

The tip protector 132 may embody any number of prior art guardsconfigured for blocking the needle tip 110 of the needle. In theexemplary embodiment shown, the tip protector 132 can embody one of theguards shown in U.S. Pat. No. 6,616,630, the contents of which areexpressly incorporated herein by reference. For example, the tipprotector 132 can have a proximal wall and two resilient arms andwherein a change in profile 144 on the needle 108, such as a crimp or abulge, engages a perimeter defining an opening on the proximal wall ofthe tip protector 132 to retract the tip protector in the proximaldirection out of the catheter hub following successful venipuncture. Thetwo arms can intersect as described in U.S. Pat. No. 6,616,630 and shownin FIG. 7 or they can run along different sides of the needle and do notintersect along a side view. The needle guard arms are spread by theneedle shaft in a ready position and engage the inside of the catheterhub, such as the guard engagement section 210 (FIG. 3) of the catheterhub 102. In an example, only part of the tip protector or needle guard132 can extend into one or more gaps of the valve opener 134 while theproximal section of the tip protector, such as the proximal wall, canextend proximally or be located proximally of the proximal most surfacesof the tip protector 132.

When the needle tip 110 is pulled into the needle guard 132 followingsuccessful venipuncture, the arms of the needle guard collapse to theirprotecting position to block accidental access to the needle tip. At thesame time, the engagement of the arms with the inside of the catheterhub is released. The same working can also be achieved by one of the onearmed needle guards described in U.S. Pat. No. 6,616,630, which runsalong a side the needle shaft, instead of crossing the needle as shownin some of the embodiments of the '630 patent. Likewise the distal wallof the one arm is pushed aside by the needle shaft in the readyposition. When the needle tip 110 is moved proximal of the distal wall,then the distal wall springs in front of the needle tip to blockaccidental access to the needle tip and at the same time the engagementbetween the needle guard and the inside of the catheter hub is released.

FIG. 5A shows a front view of a valve opener or actuator 134 and FIG. 5Bshows a cross-sectional side view of the same valve opener taken alongline 5B-5B of FIG. 5A. With further reference to FIG. 1, the valveopener 134 can comprise a ring or nose section 150 and at least oneplunger element 152, such as a leg element or an elongated extension.The nose section or ring 150 is shown in contact with the valve 136 inthe needle assembly ready to use position of FIG. 1 but can be slightlyspaced from the proximal surface of the valve. In an exemplaryembodiment, two plunger elements 152 can extend from the ring or nosesection 150 in the proximal direction and each having a length measuredin a lengthwise direction of the catheter assembly and a width, measuredorthogonally to the length. The at least one plunger element 152 issized and shaped for contact by a male Luer to transfer a distallydirected force from the male Luer to the ring 150 to then open the valve136, as further discussed below.

As can be visualized from the front view of FIG. 5A and the side view ofFIG. 5B, the at least one plunger element 152 can have an arc shape orarc cross section along a width. In another example, the at least oneplunger element 152 can be generally flat or planar. The thickness ofeach of two plunger elements 152 is sufficiently small or thin so thatthe needle guard 132 and the two plunger elements 152 have sufficientclearance to fit within the interior cross-sectional space of thecatheter hub 102 without being physically binding against the catheterhub and rendered unmovable or fixed. In an example, the thickness ofeach of two plunger elements 152 and the width of the needle guard aresuch that no undercut or channel is required to be formed in theinterior wall surfaces of the catheter 102 hub to accommodate them. Whenthe plunger element 152 has an arc cross section, it will bemechanically stronger to take a greater load when being pushed by a maletip to push the ring or nose section 150 against the valve 136. Thisallows a thin and compact design for the infusion device and gives moreroom in the standardized space of a female Luer taper.

The valve opener 134 can be made from a metal material or from a plasticmaterial. When made from a metal material, the valve opener 134 can beformed by deep draw methods and the arc shape cross section of theplunger element 152 can provide added rigidity when pushed by the maleLuer. Each plunger element 152 comprises at least two lengthwise edgesand a rib can be provided along one or both of the lengthwise edges tofurther add structural rigidity. One or more gaps 154 can be providedbetween any two plunger elements 152. The gaps 154 can provide clearanceor space for fluid flow flowing thereacross, such as during IV infusion.The gap 154 can also be utilized to accommodate a needle guard 132, asshown in FIG. 1.

The ring or nose section 150 of the valve opener 134 comprises a body158 with an outer perimeter 160. In an example, the outer perimeter 160is generally cylindrical. In other examples, the outer perimeter canhave a taper. Interiorly, the body 158 comprises a chamfer 162 and anopening 164. The distal edge, intersection, or activation end 166 of thebody 158 between the chamfer 162 and the outer perimeter 160 can have asharp edge or a blunt edge. In an example, the activation end orintersection 166 is a blunt edge comprising a planar surface for pushingagainst the valve 136, as further discussed below. On the proximal sideof the ring 150, the two plunger elements 152 can be recessed inwardlyfrom the outer perimeter 160 to form a shoulder 170. Said differently,the outer perimeter 160 can have an outside diameter of a firstdimension and the two plunger elements 152 can define an outsidediameter of a second dimension, which is smaller than the firstdimension. A shoulder 170 is provided between the two differentdimensions.

The valve opener 134 has an inside diameter measured adjacent theintersection or activation end 166. The inside diameter changes orvaries along the chamfer 162 section of the ring or nose section 150.The valve opener 134 further has a minimum inside diameter mID, whichcan be viewed as the smallest inside diameter of the valve opener. Asshown, the minimum inside diameter mID can be located at a correspondinginside location of the shoulder 170. In other examples, the minimuminside diameter mID can be located at other interior locations of thevalve opener 134, such as somewhere inside the ring 150 or somewherebetween the plunger elements 152.

FIG. 5C is a cross-sectional end view of the needle assembly 100 of FIG.1 taken along line 5C-5C and shown without the needle 108. FIG. 5C showsthe proximally facing wall surface of the proximal wall 280 of theneedle guard 132 and two plunger elements 152. As shown, the needleguard 132 is located between one or more gaps defined by the two plungerelements 152 and the proximal wall 280 extends proximally of theproximal most edges of the valve opener 134. As previously alluded to,the plunger elements 152 can each comprise an arc-shape cross section.As shown, the arc-shape cross section of each plunger element 152 isgenerally C-shaped with the concave portion facing internally towardsthe needle guard 132 and the convex portion facing outwardly away fromthe needle guard 132. The arc-shape cross section of the two plungerelements 152 should have a radius of curvature that is different thanthe radius of the female Luer of the catheter hub 102, such as a smallerradius of curvature than the female Luer of the catheter hub. The radiusof curvature of the two C-shaped plunger elements should also bedifferent than the radius of a male Luer tip. A gap can be provided oneach side edge 52 of the proximal wall 280 and the adjacent plungerelement 152.

The present configuration of the valve opener 134 allows the two plungerelements 152 to define an abutting proximal surface 54 that is sized andshaped to be pushed against by a male Luer tip or a syringe tip whensaid tip is inserted into the proximal opening of the catheter hub 102following successful venipuncture to push the valve opener 134 distallyto open the valve 136. The arc-shape cross section of each of the twoplunger elements 152 provides a sufficiently thick profile to ensureoverlapping abutting surfaces with the male Luer tip and rigidity frombuckling. Consequently, the C-shaped plunger elements can avoiddeflection when pushed by a syringe tip or other male Luer tip, avoidslippage of the syringe tip or Luer tip missing the end surfaces 54 ofthe plunger elements 152 when the syringe tip or Luer tip is insertedinto the open proximal end of the catheter hub, and/or avoid a situationin which the syringe tip or Luer tip is pushed between the two plungerelements to wedge the two plunger elements between the tip and theinterior surface of the catheter hub 102 during activation of the valveopener 134.

FIG. 5D shows the same cross-section end view of a catheter hub 102 asthat of FIG. 5C but with an alternative arc-shape cross-sections on theplunger elements 152 of the valve opener 134. As shown, the two plungerelements 152 each comprises a C-shaped cross-section. However, in thepresent embodiment, the concave portion of the arc-shape cross-sectionof each plunger element 152 faces outwardly, away from the needle guard132, while the convex portion of each plunger element faces inwardlytowards the needle guard 132. Like the embodiment of FIG. 5C, thearc-shape cross-section of the two plunger elements 152 provideoverlapping abutting surfaces with a syringe tip or Luer tip when thesame is inserted into the catheter hub 102 to push the valve opener 134into the valve to open the valve following successful venipuncture.

When mounted inside the interior cavity 130 of the catheter hub 102, thering or nose section 150 of the valve opener 134 is elastically deformedand then expands when it reaches a recessed hub section 174 of thecatheter hub 102, which can accommodate the ring or nose section withoutdeforming the ring. Alternatively, the catheter hub 102 is designed toexpand to allow the assembly of the valve opener 134. A shoulder 176(FIG. 4) is provided at the recessed hub section 174, which forms aphysical stop for engaging the shoulder 170 on the valve opener 134.This allows the valve opener 134 to be retained within the interiorcavity 130 of the catheter hub 102 during needle withdrawal and duringuse, when the valve opener 134 is pushed distally to activate the valveand subsequently moves proximally when the male Luer is removed, thusallowing the valve to close.

With reference again to FIG. 1, the valve 136 is located inside thecatheter hub 102 just distal of the nose section or ring 150 of thevalve opener 134. In an example, the valve 136 embodies a valve disccomprising a valve body comprising a valve diameter, a valve thicknessmeasured orthogonal to the valve diameter, and one or more slitsdefining two or more flaps. As used herein, valve disc and valve diskare similar or the same unless the context indicates otherwise. In aparticular example, three slits are provided through the valve thicknessto define three flaps. The three slits can originate from a point andextend radially from about a center point or central portion of the bodyof the valve 136, similar to a three-point star, to form three flapsthat can deflect along the slits. The valve 136 can comprise an outerperimeter that can float inside the interior cavity of the catheter hub,between the valve opener 134 and the bushing 138. For example, the outerperimeter of the valve 136 can move proximally and distally within theinterior cavity 130 of the catheter hub 102 and not be restrained by thecatheter hub along an axial direction of the catheter assembly. Theouter perimeter of the valve 136 can be the same or smaller or largerthan the outer perimeter of the valve opener or ring 150 of the valveopener 134. However, at least some part or all of the distal edge,intersection, or activation end 166 of the nose section or ring 150 isrecessed from the outer perimeter of the valve 136 so that the distaledge 166 can abut or touch the proximally facing wall surface of thevalve 136, as further discussed below. Also, since the valve 136 canfloat, the valve can be positioned inside a single hub body catheter hub102. In other words, the valve 136 does not have to be retained inside acatheter hub by two or more catheter hub bodies, such as along a seam oftwo or more hub bodies. However, the various components described hereinmay readily be used with a multi-piece catheter hub without deviatingfrom the scope of the present disclosure.

FIG. 6A shows an end view of a bushing 138 and FIG. 6B shows across-sectional side view of the same bushing taken along line 6B-6B ofFIG. 6A. With further reference to FIG. 1, the bushing 138 comprises abody 190 comprising a first body section 192, a second body section 194extending from the first body section 192 having a cone shape, and twoor more leg extensions 196 extending from the second body section 194.The first body section 192 can have an elongated body that can have acylindrical shape with an optional tapered distal tip or nose section.In some examples, a generally cylindrical ring extends from the secondbody section 194 and the two or more leg extensions 196 extend from thecylindrical ring. One or more gaps 200 are provided between two adjacentleg extensions 196. In an example, the number of leg extensions 196incorporated with the bushing 138 is the same as the number of flapsincorporated with the valve 136. Thus, if the valve has three flaps,then there can be three leg extensions 196 on the bushing 138. If thevalve 136 has a single slit, then there can be two leg extensions 196.The leg extensions 196 on the bushing 138 can define an outside diameterthat is smaller than the minimum inside diameter mID of the valve opener134. The proximal tip 204 of each leg extension 196 can have a chamferor a blunt tip. In one example, a chamfer 206 is incorporated at theproximal tip 204 of each leg extension 196 and wherein the chamfer 206tapers inwardly from the exterior of the leg extension 196. This chamferdirection is configured to match the folding direction of the flaps onthe valve 136. The bushing 138 can be made from a metal material and theleg extensions 196 can be unitarily formed with the body 190.Alternatively, the leg extensions 196 can be welded to the body 190.

When positioned in the catheter hub 102, the bushing 138 and the valve136 are oriented so that the leg extensions 196 on the bushing arealigned with the flaps on the valve. In other words, the two componentsare aligned so that when the valve 136 is advanced distally by the valveopener 134 from the proximal side, as further discussed below, the flapson the valve are pushed into physical contact with the leg extensions196 on the bushing 138. Thus, if there are three flaps on the valve, thethree flaps will be pushed into physical contact with three legextensions on the bushing. The distally facing wall surface of the valve136 can touch the leg extensions 196 and/or a resilient element 276 orbe spaced from the leg extensions 196 on the bushing 138 and/or theresilient element 276 in the valve closed position and be pushed againstthe leg extensions during use. In other examples, the valve can touchthe proximal tips of the leg extensions and/or the resilient element 276in the closed position of the valve or be spaced therefrom. If spacedfrom the leg extensions 196 and/or the resilient element 276, the valve136 can be displaced axially into contact therewith.

FIG. 6C shows an end view of an alternative bushing 138 and FIG. 6Dshows a cross-sectional side view of the same bushing taken along line6D-6D of FIG. 6C. Like the bushing of FIG. 6A, the present embodimentcomprises a body 190 comprising a first body section 192 and a secondbody section 194. In the present embodiment, three leg extensions 196are provided for use with a valve comprising three slits defining threelugs, as previously alluded. The three leg extensions 196 can be equallyspaced along a circumference of the second body section 194. In anotherexample, the three leg extensions 196 can be located and spaced inaccordance with the positions of the lugs on the valve 136 so that whenassembled inside the catheter hub 102, the valve can be pushed distallyby the valve opener or valve actuator 134 and the leg extensions 196 onthe bushing 138 are aligned to push the lugs of the valve in theproximal direction to open the valve, as further discussed below. Withreference now to FIG. 2, the catheter assembly 100 is shown in atransition position whereby the needle 108 is in the process of beingseparated from the catheter hub 102 and the catheter tube 104, such asfollowing successful venipuncture. The needle tip 110 is shown justdistal of the valve 136. During retraction of the needle 108 in theproximal direction, the tip protector 132 is held axially by theengagement between one or both resilient arms on the tip protector 132and a guard engagement section 210 (FIGS. 3 and 4) on the catheter hub102. In an example, the guard engagement section 210 is a surfacediscontinuity formed on the interior surface of the catheter hub 102.For example, the guard engagement section 210 can comprise a section ofa first inside diameter and a section of a second inside diameter, whichis larger than the first inside diameter. The guard engagement section210 can embody an internal projection or a groove or a combination ofboth a groove and a projection formed on the interior surface of thecatheter hub 102. When a combination of a groove and a projection isused for a guard engagement section 210 to engage the needle guard ortip protector 132, then it is preferred that the groove is distal to theprojection. In an example, two spaced-apart guard engagement sections210 are provided for engaging the two resilient arms on the tipprotector 132. The two guard engagement sections 210 can be locateddiametrically opposed to each other just distal of the section of thefemale Luer taper of the catheter hub 102.

FIG. 5E shows a valve opener 134 provided in accordance to analternative embodiment of the present disclosure. The present valveopener 134 is similar to the valve opener 134 of FIGS. 5A and 5B andcomprises a nose section 150 with an activation end 166 and two plungerelements 152 extending in the proximal direction of the nose section150. However, rather than incorporating two plunger elements 152 withtwo free ends, the present embodiment incorporates a band or ringconnecting the two plunger elements 152 together. Two arc-shape, curvedsections, or stabilizer elements 253 can attach to the two plungerelements 152 to form the band or ring 255. The band 255 can be called astabilizing ring 255 and can connect the two plunger elements 152together to form a stabilizing structure. The stabilizing ring 255 formsa continuous perimeter section of the valve actuator that is spaced fromanother continuous perimeter section defined by the nose section 150 ofthe valve actuator.

The present valve actuator embodiment 134 can also be viewed as a valveopener 134 with a single plunger element 152 extending from a nosesection 150 and wherein the single plunger element 152 comprises two ormore reliefs or through passages 61 formed through the wall of theplunger end. The needle guard 132 can engage the edges or perimeters 65of the reliefs 61 in the ready to use position and during retraction ofthe needle following successful venipuncture. Alternatively, the tipprotector or needle guard 132 can project from the holding space definedby the valve opener 134 through the reliefs 61 to engage the interiorsurface of the catheter hub 102. Still alternatively, the tip protector132 can project through the reliefs 61 but not contact the interior ofthe catheter hub or the perimeters 65. Still alternatively, the tipprotector 132 can project through the reliefs 61, contacts the interiorof the catheter hub, and contacts one or both perimeters of the reliefs.The part of a tip protector that can project through one or both reliefscan be one or two elbows of a tip protector.

The needle guard 132 (FIG. 7) of the present embodiment can bepositioned, at least in part, in a holding space 155 of the valve opener134. When situated in the holding space 155, the needle guard or tipprotector can project through one or both reliefs 61 of the valveopener. The part or parts of the needle guard that project through cancontact the interior of the catheter hub, be spaced from the interior ofthe catheter hub, can contact one or both perimeters 65 of the reliefs,or be spaced from one or both perimeters of the reliefs, or combinationsthereof. The part of the needle guard that projects can be one or twoelbows of a needle guard.

Thus, in the embodiment with two reliefs or through passages 61, theperimeters of the two reliefs or through passages can function as guardengagement sections 210 by allowing the elbows of the tip protector toengage thereto. Alternatively, the two elbows of the needle guard canproject through the two reliefs from the holding space defined by thevalve opener to engage the guard engagement sections or segments formedon the interior surface of the catheter hub. Thus, the perimeters of thereliefs or the interior surfaces of the catheter hub can form anchorpoints for the arms of the tip protector to engage thereto in the readyto use position and during retraction of the needle following successfulvenipuncture.

In an example, the single plunger element 152 of the valve opener 134 ofFIG. 5E can embody a generally cylindrical body section 151 having aninterior surface 153 defining a bore having a path or channel 154, whichcan also be a gap for fluid flow, and a proximal perimeter or end edge63. A guard engagement section 210, similar to the guard engagementsegment 210 shown in FIG. 4, can be formed on the interior surface 153of the present valve opener 134. In other words, the projection, bump,recess or guard engagement section 210 can be formed on the interiorwall surface 153 of the valve opener to allow engagement between theneedle guard and the interior surface of the valve opener.

When the present alternative valve opener 134 of FIG. 5E is used with aneedle device or catheter assembly 100, such as the assembly of FIG. 1,the guard engagement segment 210 can be on the catheter hub, on theinterior wall of the valve opener, or a perimeter of a relief formedthrough the wall of the valve opener. There can be one or more reliefsor guard engagement segments incorporated with the valve opener. Therecan also be one or more guard engagement segments formed with thecatheter hub for use with the one or more reliefs of the valve opener.This allows the two resilient arms of the tip protector 132 to engagethe valve opener 134 or to engage the catheter hub by projecting throughthe reliefs.

In yet another example, two openings 61 shown in dashed-lines (only oneshown) can be provided through the wall layer of the cylindrical bodyportion 151 of the valve opener for use with the guard engagementsegment 210 formed with or on the interior of the catheter hub 102. Inthe ready to use position using the valve opener of the presentalternative embodiment, the resilient arm or arms of the tip protector132 can project through the opening 61, or through two openings 61, toengage the guard engagement segment(s) 210 of the inside of the catheterhub 102 instead of or in addition to engaging the opening 61 of thevalve opener 134.

FIG. 3 shows the needle 108 completely removed from the catheter hub 102and the tip protector 132 covering the needle tip 110 (FIG. 1) in aprotective position. In transitioning from the position of FIG. 2 to theposition of FIG. 3, the needle tip 110 moves proximally of two distalwalls 300, 302 (FIG. 7), one on each end of the resilient arms 288, 290(FIG. 7), of the tip protector 132. Alternatively, the needle guard 132can have one distal wall and/or one arm. As the two distal walls andhence the two resilient arms are no longer biased outwardly by theneedle 108, the two arms 288, 290 move radially to disengage from thetwo guard engagement sections 210 of the catheter hub 102, or of thevalve opener 134 (FIG. 5E), if the latter is alternatively used.Alternatively, the one arm and one distal wall disengage from the oneguard engagement section 210.

As the needle continues to move in the proximal direction and the changein profile 144 (FIG. 1) engages the perimeter 282 (FIG. 7) on theproximal wall of the tip protector 132, the tip protector 132 is movedproximally with the needle to the position shown in FIG. 3.Alternatively the needle guard can clamp onto the needle shaft and beremoved from the catheter hub as a unit. Note that in the protectiveposition in which the tip protector 132 covers the needle tip, the valve136 remains inside the interior cavity of the catheter hub 102. Thus,the valve 136 is located inside the catheter hub 102 in both the readyposition of the needle and the protective position of the needle. Viewedfrom another perspective, the valve 136 is located inside the catheterhub 102 in both the ready to use position of the catheter assembly 100,in which the needle tip projects out a distal opening 112 (FIG. 1) ofthe catheter tube 104, and a protective position of the catheterassembly, in which the needle is removed from the catheter hub and theneedle tip is covered by a tip protector.

With reference now to FIG. 4, the catheter hub 102 is shown with a malemedical implement 220 positioned in the proximal opening thereof. Themale medical implement or instrument 220 can be a male Luer, a syringetip, an IV set connector, or other male tip having a Luer taper. Forexample, the male medical implement can be connected to an IV tubing,which is connected to an IV fluid source for fluid delivery through themale medical implement 220, the catheter hub 102, and the cathetertubing 104 to deliver fluid therapy to a patient.

With reference to FIGS. 5A, 5B, 6A, 6B, and continued reference to FIG.4, when initially inserting the male medical implement 220, herein maletip, into the proximal opening of the catheter hub 102, the male tipinitially contacts the two plunger elements 152 on the valve opener 134to advance a distally directed force on the two plunger elements 152 toopen the valve 136. The arc cross section of the plunger elements 152can have a smaller diameter than the inside diameter of the catheter hub102 to provide a larger contact surface for the distal end of the malemedical instrument 220, as previously discussed. This can also bedesigned to contact the inside wall of the catheter hub at a tangentialpoint. In this way, the plunger elements 152 are stable and can resistbeing deflected outwards. This arrangement can avoid the relatively thinplunger elements from wedging between the male medical instrument 220and the inside wall of the catheter hub 102. The distally directed forcemoves the valve opener 134 in the distal direction until the geometriesof the male tip 220 and the proximal opening of the catheter hub stopfurther distal advancement of the male tip. In an example, a female Luertaper of the catheter hub 102 and a male Luer taper of the male tip 220register and block distal advancement of the male tip further into theopening of the catheter hub. A seal is provided by the Luer engagementto prevent fluid from leaking out the proximal opening of the catheterhub.

As the valve opener 134 moves distally by the distal advancement of themale tip 220, the ring 150 is urged distally and pushes against theproximally facing surface of the valve 136. In particular, the distaledge 166 of the valve opener 134 initially pushes against the proximallyfacing surface of the valve 136. As the valve 136 is axially movableinside the catheter hub 102, the valve 136 is urged distally by thevalve opener 134, which is urged distally by the male tip 220. Forexample, the ring 150 contacts and pushes the valve 136 in the distaldirection. However, due to the presence of the leg extensions 196 on thebushing 138, the outer edges or outer valve sections of the valve 136moves distally while other parts on the valve 136 that abut or contactthe leg extensions 196 are stopped from moving distally by the legextensions 196. In effect, the outer edges of valve 136, such as outersections of the body of the valve 136, move distally while the flaps onthe valve are deflected from a central point or location radiallyoutwardly and in a proximal direction by the leg extensions 196 on thebushing 138 to open a flow path 226 through the valve. Fluid from themale tip 220 can then flow through the catheter hub 102, through thevalve 136, and through the lumen of the catheter tube 104.Alternatively, a suction can be applied by the male medical instrument,such as a syringe or vacuum blood collection tube, and blood aspiratedfrom the patient. This is often done for testing samples before infusiontherapy is commenced. Also, typically any remaining blood is firstflushed from the inside of the catheter hub 102 before infusion therapyis commenced.

With further reference to FIGS. 4, 5B and 6B, the chamfer 162 on thering 150 and the chamfers 206 on the leg extensions 196 facilitatedeflection of the flaps on the valve radially outwardly and in theproximal direction. Also, the relative diameters defined by the legextensions 196 and the minimum inside diameter mID of the valve opener134 allow the valve opener and the bushing to deflect the valve 136therebetween to open the valve. Alternatively, the outer perimeter ofthe valve can remain in contact with the inside wall of the catheterhub, when pushed distally, with only the flaps opening around the slitor slits.

Thus, an aspect of the present disclosure is understood to include acatheter assembly comprising a valve comprising one or more slits andtwo or more flaps wherein the valve comprises parts or sections thatmove in a distal direction and parts or sections that open along aradial direction and in a proximal direction to open a flow path throughthe valve. In an example, outer edges of the valve are configured tomove distally while the flaps of the valve are configured to moveradially outwards to open a flow path through the valve. Also, byincorporating a valve that can move in this fashion to open a fluid flowpath, the actuation distance that the valve opener 134 has to travel inthe axial direction of the catheter assembly is minimized compared to avalve having flaps that only open in the distal direction by a valveopener. Thus, the size of the catheter hub 102, such as the length ofthe catheter hub, can be reduced compared to one that utilizes a valveand a valve opener that opens the valve by deflecting the valve flapsonly in the distal direction.

A further aspect of the present disclosure is understood to include acatheter assembly comprising a valve and wherein the valve perimeter canfloat in the axial direction relative to the catheter hub. In otherwords, by incorporating a valve with a valve perimeter that can float inthe axial direction, a two-part catheter hub is not required to securethe valve perimeter therebetween and inside the catheter hub. Therefore,a catheter hub with a singularly formed hub body may be used with thepresent catheter assembly. Thus, the size of the catheter hub 102, suchas the outer diameter or dimension of the catheter hub, can be reducedcompared to one that utilizes a two-part hub body. The two part hub bodywhere they join along a seam can thus be reduced to provide a catheterassembly with a relatively smaller outer profile.

A still yet further aspect of the present disclosure is understood toinclude a valve opener 134 for opening a valve 136. The valve opener 134is configured to push the valve against another structure, such as theleg extensions 196 on the bushing 138. The present valve opener 134 maybe viewed as having a multi-piece valve opening structure. For example,the part with the ring 150 and the plunger elements 152 may be viewed asa proximal valve opener 250 and the bushing 138 with the leg extensions196 may be viewed as a distal valve opener 252. The two valve openers250, 252 cooperate to open the valve 136. As described, the proximalvalve opener 250 is sized and shaped to push against the outer edges ofthe valve 136 in the distal direction to move the valve against thedistal valve opener 252. The distal valve opener 252 is sized and shapedto push the flaps on the valve in a radially outward direction and partof the flaps in a proximal direction to open a fluid path or flow path226 through the valve 136. In an example, the leg extensions 196 on thedistal valve opener 252 are axially fixed and by pushing the flaps ofthe valve in a distal direction against the leg extensions, the flapsare deflected radially outward by the leg extensions on the distal sideof the valve 136. In other words, when the valve is actuated to open aflow path through the valve, the valve is being physically pushed by anactuator on a proximal side of the valve and an actuator on the distalside of the valve. In a particular embodiment, the valve can be actuatedto open a flow path through the valve by being physically pushed by aring on a proximal side of the valve and leg extensions on the distalside of the valve.

In the valve open position of FIG. 4, the proximal tips 204 of the legextensions 196 and the distal edge 166 of the ring 150 are spaced from aplane drawn orthogonally to the lengthwise axis of the catheterassembly. In other words, the proximal tips 204 of the leg extensions196 and the distal edge 166 of the ring 150 do not overlap from theperspective of this plane and a gap is provided between the two toaccommodate the valve 136 therebetween. In another example, the proximaltips 204 of the leg extensions 196 and the distal edge 166 of the ring150 do overlap along an axial direction, which has the effect ofdeflecting the flaps radially outwards a relatively greater amount thanwhen there is no overlapping. Further, because the flaps are pushedagainst axially fixed leg extensions 196 on the bushing, the flaps aredeflected backwards in the proximal direction by the leg extensions 196.In yet other examples, the proximal tips 204 of the leg extensions 196and the distal edge 166 of the ring 150 just touch along a plane drawnorthogonally to the lengthwise axis of the catheter assembly.

In a still further aspect of the present disclosure, a catheter assemblyis provided comprising a valve, a proximal valve opener, a distal valveopener, a needle hub with a needle, and a catheter hub with a cathetertube. The valve assembly can further include a tip protector forblocking the needle tip in a needle protective position. Followingsuccessful venipuncture, a male tip, such as a male Luer, can beinserted into a proximal opening of the catheter hub to advance theproximal valve opener in a distal direction, which moves the valve in adistal direction against the distal valve opener. However, rather thandeflecting the flaps in a radially outward and distal direction to opena fluid path through the valve, the flaps are pivoted in a proximaldirection to open the fluid path through the valve. For example, thetips of each of the flaps of the valve, which typically originate from apoint or origin near a central location of the valve, are deflected in aproximal direction by the leg extensions 196 of the bushing of thepresent device. In an example, the flaps are deflected in the proximaldirection by pushing the flaps against stationary leg extensions 196 ona distal valve opener 252. In other words, the flaps on the valve can bedeflected in a proximal direction by a structure located distally of thevalve and abutting a distally facing surface of the valve 136. Thedistal valve opener 252 can be a metal bushing having a body with a coneshaped section having two or more leg extensions extending therefrom ina proximal direction. The bushing may also be made from a thermoplasticmaterial.

To change the male tip 220 or to simply close the valve 136 from theopen position of FIG. 4, the male tip 220 is removed in the distaldirection away from the catheter hub 102. The biasing or resilientnature of the valve 136, which can be made from an elastomer, allows thevalve to recoil to its more relaxed state. Thus, the flaps on the valvewill recoil by moving distally while the outer edges or outer sectionsof the valve body recoil proximally, which pushes the proximal valveopener 250 in the proximal direction and the shoulder 170 on theproximal valve opener 250 towards or against the shoulder 176 inside theinterior cavity of the catheter hub. The valve 136 and the proximalvalve opener 250 therefore return to substantially the position shown inFIG. 3 after removal of the male tip from the catheter hub.

Alternatively or optionally, a softer material (not shown) resilientelement 276 than the valve 136 may be placed between the distal surfaceof the valve and an inside distal step or shoulder 274 of the catheterhub 102, which is shown schematically in FIGS. 1-4. The resilientelement 276 can be a coil spring, a leaf spring, or an elastomericcylinder. The resilient material 276, if incorporated, can provide extrabiasing force to return the valve 136 to a closed position when the malemedical instrument 220 is removed. The elastic component or resilientelement 276 can be spaced from the valve 136 in the ready to useposition shown in FIG. 1 or can contact the valve in the ready to useposition.

The valve 136 may be opened again by placing a male tip 220 into theproximal opening of the catheter hub 102 and pushing the proximal valveopener 250 in the distal direction, as described above with reference toFIG. 4.

FIG. 7 is a rear isometric view of the needle guard 132 of FIG. 1. Theneedle guard 132 is exemplary only as needle guards with other ordifferent features may be used instead of the exact needle guard 132shown in FIG. 7. In the present embodiment, the needle guard 132comprises a proximal wall 280 comprising a perimeter 282 defining anopening 284. The proximal wall 280 has a proximally facing wall surface286 and a distally facing wall surface opposing the proximally facingwall surface. At least one resilient arm 288 extends distally of theproximal wall 280. As shown, two resilient arms 288, 290 extend distallyof the proximal wall. One arm can be longer than the other arm. Each armcan also include different arm widths, including a first arm section 292of a first width and a second arm section 294 of a second width, whichis smaller than the first width. The two arms can originate fromdifferent ends of the proximal wall 280 and can cross one another attheir respective second arm sections 294. Thus, when viewed from a sidealong the lengthwise direction of the needle guard 132, the two armsintersect one another. When used with a needle, the two arms 288, 290intersect one another when in a ready to use position and when in theprotective position. In an alternative embodiment, the two arms 288, 290originate from different ends of the proximal wall and extend in adistal direction without crossing one another. Thus, the two arms 288,290 can also have essentially the same arm width along the length ofeach respective arm.

A distal wall 300, 302 is provided at an end of each arm 288, 290. Thedistal walls 300, 302 can overlap one another along an axial directionof the needle guard by utilizing different arm lengths and/or anglingone of the walls at an elbow or diagonal section 304 between the distalwall and the resilient arm. In an example, the elbow or diagonal section304 of each arm, if two arms are utilized, can engage a correspondingguard engagement section 210 inside the catheter hub 102, inside thevalve actuator 134, or against a restraining or restricting surface(s)or choke point(s) of one or two reliefs of the valve actuator 134 toremovably secure the needle guard inside the catheter hub in the readyposition and during the transition process of removing the needle 108from the catheter hub 102. When the radial profile of the needle guard132 measured at the one or two elbows 304 reduce in size, such asfollowing movement of the needle tip proximally of the two distal walls300, 302, the needle guard 132 can move proximally of the choking orchoke point to be removed from the catheter hub 102 with the needle.When the two distal walls move radially, the needle guard reduces itsradial profile. The needle guard 132 may be folded from a stamped metalsheet to form the guard as shown. Ribs may be formed on the arms, theproximal wall, and/or the distal walls to increase structurallyrigidity.

With reference now to FIG. 8A, a front view of an exemplary valve 136provided in accordance with aspects of the present disclosure is shown,which may be usable with the catheter assemblies and hubs with a femaleLuer described elsewhere herein. The valve 136 is shown with a valvebody 320 having a width measured from one edge to another edge of theouter perimeter 322 of the valve body. The width of the valve body inthe present embodiment is the same as the diameter of the valve bodybecause of the circular configuration of the exemplary valve. The valvebody 320 has a thickness, which is the dimension that extends into thepage of FIG. 8A or orthogonal to the width. The valve 136 is shown witha single slit 324 formed through the thickness of the valve body 320,which defines a first flap 326 a and a second flap 326 b. The flaps cancollectively generally be referred to with element number 326. The firstflap 326 a and the second flap 326 b can be deflected to open a flowpath 226 through the valve body 320. The first flap and the second flapcan be deflected by pushing the valve 136 with a valve opener on aproximal side of the valve into leg extensions on a distal side of thevalve, as previously discussed.

FIG. 8B is a front view of an exemplary valve 136 provided in accordancewith further aspects of the present disclosure, which may be usable withthe catheter assemblies and hubs with a female Luer described elsewhereherein. The present valve 136 is similar to the valve of FIG. 8A with afew exceptions. In the present embodiment, three slits 324 are providedthrough the thickness of the valve body to form three flaps 326 a, 326b, 326 c. The three slits 324 can intersect at a single central point328. The first flap 326 a and the second flap 326 b can be deflected toopen a flow path 226 through the valve body 320. The first, second andthird flaps 326 a, 326 b, 326 c can be deflected by pushing the valve136 with a valve opener on a proximal side of the valve into legextensions on a distal side of the valve, as previously discussed. Afluid flow path 226 is provided when the three flaps are deflected. Inan example, the flaps 326 a, 326 b, 326 c near the central point 328expand radially towards the outer perimeter 322 and in the proximaldirection when deflected by leg extensions on the distal side of thevalve 136. As there are three flaps 326 a, 326 b, 326 c, the presentvalve is configured to be used with a bushing having at least three legextensions, as shown in FIGS. 6C and 6D.

FIG. 8C is a front view of an exemplary valve 136 provided in accordancewith still further aspects of the present disclosure, which may beusable with the catheter assemblies and hubs with a female Luerdescribed elsewhere herein. The present valve 136 is similar to thevalve of FIG. 8A with a few exceptions. In the present embodiment, thesingle slit 324 for forming a first flap 326 a and a second flap 328 bis provided with reliefs 340, 340 at both ends of the slit 324. In anexample, the reliefs 340, 340 embody two short through cuts 340 a, 340 bat each end of the slit 324 forming a V-shaped relief 340. The tworeliefs 340 and 340 provide clearance for the two flaps 326 a, 326 b toenable them to deflect more readily when pushed against the legextensions with fewer restrictions at points near the two ends of theslit 324 when no reliefs are incorporated. Less preferably, a singleshort through cut may be incorporated at each end of the slit 324.

FIG. 9 is an exploded, perspective top view of a catheter assembly 400provided in accordance with further aspects of the present disclosure.As shown in FIG. 9, the catheter assembly 400, which may more broadly bereferred to as a needle assembly or a needle device, is showncomprising, a catheter hub 102 with a catheter tube 104 and a bushing138. The bushing 138 can be configured to wedge the proximal end of thecatheter tube 104 against the interior wall surfaces of the catheter hub102 to retain the catheter tube 104 to the catheter hub 102.

Interiorly of the catheter hub 102, a septum or valve 136, an actuatoror valve opener 134 and a safety clip 132, such as a needle guard or tipprotector, are provided. A needle 108, which has a change in profile144, can be inserted through the proximal opening of the catheter hub102 with the needle tip protruding from the distal opening 112 of thecatheter tube in a ready to use position, as shown in FIG. 9A. A cannulahub or needle hub 106 can attach to the proximal end of the needle 108and can contact the proximal end of the catheter hub 102 when assembledthereto in the ready to use position. The proximal opening of thecatheter hub 102 can be sized with a female Luer taper, optionally withexternal threads, to engage with a male Luer tip in a Luer slip or aLuer lock.

The tip protector 132 is configured to be removed with the needle 108following use and the valve 136 and valve actuator 134 remain with thecatheter hub 102 for controlling fluid flow therethrough. The actuator134 is configured to be pushed distally by a male tip into the valve 136to open the valve for fluid flow, as further discussed below.

A flash back plug or blood stopper assembly 114 can be connected to theneedle hub 106 to stop blood flow out the flashback chamber 116 of theneedle hub 106. The flash back plug 114 can be provided at the proximalend the needle hub 106 to allow air to vent but stops blood fromspilling out the proximal end of the body of the flash back plug 114,which has a chamber 114 a and a hydrophobic filter 114 b is assembled inthe chamber. Alternatively, a syringe can be attached to the proximalend of the needle hub 106. A second valve 136 and actuator 134 describedfurther below can also be placed within the needle hub 106.

A protective cap 124 with a sleeve 124 a and a saddle 124 b can beprovided to cover the needle 108 during packaging and before use, whichis conventional. The saddle 124 b can surround at least part of thecatheter hub 102 and the needle hub 106 and be removably engaged to theneedle hub.

FIG. 9A is an isometric cut-away view of the needle assembly 400 of FIG.9 in an assembled state. The catheter hub 102 is shown with an optionalpair of wings 126 extending radially of the hub body. When incorporated,the wings 126 can add stability by providing an increased surface areafor resting and securing the catheter hub 102 against the skins of apatient, such as following intravenous access.

FIG. 9B is an isometric view of the assembled needle assembly 400 ofFIG. 9, showing the removable cap 124 disposed over the needle andengaging the needle hub 106.

The catheter assembly 400 of the present disclosure is similar to thecatheter assembly 100 of FIG. 1 with a few exceptions. With reference toFIG. 10A, a schematic cross-sectional side view of the catheter assembly400 of FIG. 9 is shown. The catheter assembly 400 comprises the catheterhub 102 with the catheter tube 104 (partially shown) extending out adistal end thereof and the needle 108 attached to the needle hub 106(partially shown) and the needle projecting through the catheter hub 102and the catheter tube 104 in the ready to use position.

In the ready position with the needle hub 106 in contact with thecatheter hub 102 and the needle tip extending out the distal end ordistal opening 112 (of FIG. 9) of the catheter tube 104, the catheterassembly 400 is ready for use, such as to perform a venipuncture orintravenous access. Normally a protective cap (not shown) is removedfrom the catheter assembly or needle assembly 400 before the device isseen as depicted in FIG. 10A.

Located internally of the catheter hub 102 is the valve 136 having avalve body 320 with an outer perimeter, a valve disc 410 and a valveskirt 412 extending in an axial direction from the valve disc. In anexample, the valve disc 410 comprises one or more slits defining one ormore flaps to be opened/closed by the valve actuator 134. The type ofslits and flaps and the numbers of each incorporated with the valve disc410 can resemble those shown with the different valve embodiments 136 ofFIGS. 8A-8C. In an embodiment, the valve skirt 412 is positioned in arecessed section 420 formed in the interior cavity 130 of the catheterhub 102, which prevents the valve 136 from axially moving once situatedinside the catheter hub 102.

In an example, the recessed section 420 has a distal shoulder 420 a anda proximal shoulder 420 b (FIG. 10B) defining a groove therebetween. Thevalve skirt 412 has a length that is sized and shaped to fit within thegroove. In an example, the valve skirt 412 contacts the proximalshoulder 420 b while the valve disc 410 contacts the distal shoulder 420a. Viewed differently, the valve 136 of FIG. 10A can contact the distalshoulder 420 a and the proximal shoulder 420 b of the recessed section420 and be restrained thereby in the ready to use position so that thevalve skirt 412 is axially fixed or not axially movable.

In an example, the outer diameter or exterior surfaced of the skirtsection 412 forms a snug fit or size-on-size fit with the recessedsection 420 of the interior 130 of the catheter hub 102. In otherexamples, a slight inference fit is provided between the two. In stillother examples, a small clearance is provided between the exteriorsurface of the skirt section 412 and the interior surface at therecessed section 420 with the valve skirt 412 in contact with theproximal shoulder 420 b and the valve disc 410 in contact the distalshoulder 420 a of the recessed section.

A distal cavity chamber 130 a is provided distal of the valve disc 410and proximal of the bushing 438. In some examples, a helical spring or aresilient biasing element, such as an elastomeric ring or cylinder, maybe provided in the distal cavity chamber 130 a, concentric with theneedle, to bias the flaps of the valve disc 410 to assist the valve discto close the one or more slits, similar to the resilient element 276 ofFIGS. 1-4.

In an example, the valve disc 410 comprises a valve diameter, a valvethickness measured orthogonal to the valve diameter, and one or moreslits defining two or more flaps, as previously discussed. In theillustrated embodiment, the valve skirt 412 extends axially to thelengthwise axis of the valve and has an elongated wall that is generallyperpendicular to the outer perimeter of the valve disk 410, forming agenerally cylindrical valve body. In some embodiments, the valve skirt412 may be sloped such that the valve forms a frusto-conical structure.

The valve skirt 412 defines a valve cavity 424 having an open proximalend 426 through which the actuator nose or nose section 430 of the valveactuator 134 can advance and actuate the valve flaps of the valve disc410. In one embodiment, at least some part of the actuator nose 430including the distal actuation end 436 of the valve actuator 134 islocated inside the valve cavity 424 of the valve 136 prior to actuation.Thus, the actuator nose 430 can be narrower than the inside diameter ofthe valve skirt 412 so that the actuation end 436 fits within the valvecavity 424 and abuts or touches the valve disc in the ready to useposition. In an example, the relative dimensions are such that the nosesection 430 of the actuator does not touch the interior wall surface ofthe skirt section 412 with some touching contemplated.

In an example, the actuation end 436 contacts the proximally facingsurface of the valve disc 410 in the ready to use position and anotherpart of the valve actuator 134, such as one or two projections 442 (FIG.10B), abuts a shoulder 452 inside the catheter hub to impart a load onthe valve disc in a ready to use position but not enough to open the oneor more slits, as further discussed below. In other examples, theactuation end 436 is spaced from the proximally facing surface of thevalve disc 410 in the ready to use position and the projection orprojections 442 on the actuator either contact the shoulder 452 or arealso spaced from the shoulder 452. When the one or more projections onthe actuator 134 are spaced from the shoulder 452 and the actuation end436 is spaced from the valve disc 410, the actuator can float within thecatheter hub by a small amount in the axial direction.

In an example, the valve actuator 134 comprises a nose section 430,which is elongated in structure and can be generally cylindrical or havea draft angle or taper that terminates in an actuation end 436. Theactuation end 436 can have a blunt distal end surface or has a sharpedge. The nose section 430 can have a wall surface with a continuouscircumference or continuous perimeter section, without a gap or slit,such as a cylinder with a continuous wall. The nose section 430 candefine a bore. In some examples, a plurality of spaced apart slitsand/or openings can be provided on the nose section 430 to permit flowor fluid flushing.

Two actuating elements or plunger elements 152 can extend proximally ofthe nose section 430. For example, the two plunger elements 152 can beunitarily formed with the nose section 430 and can extend from the nosesection in the proximal direction. A gap or space can be providedbetween the two plunger elements 152 for positioning the needle guard ortip protector 132 therebetween. In other words, the two plunger elements152 each comprises at least two lengthwise edges and the edges arespaced from one another. The lengthwise edges of the plunger elements152 can align with a lengthwise axis of the valve opener.

In an example, a projection 442 extends outwardly from an outer surfaceof one or both plunger elements 152. As shown, a projection 442 extendsfrom the outer surface of each plunger element 152. Each projection 442resembles a ramp surface having a generally flat edge for abutting theshoulder 452. The ramp surface of the projection 442 and the directionof the ramp allows the actuator 134 to be inserted into the interior ofthe catheter hub and be seated within the second recessed section 450,as further discussed below.

In an example, a transition section 440 extends from the nose section430 and widens axially in the proximal direction. The two actuatingelements 152 can extend from the transition section 440. The twoactuating elements can extend from the nose section. Some embodimentsmay utilize other shapes for the nose section 430, such as cuboid,rectangular, conical, pyramidal, chamfered or the like.

In an example, the actuator or valve opener 134 has a lengthwise axis,the one or more actuating elements 152 extend axially or parallel to thelengthwise axis. In a particular example, two actuating elements 152 arediametrically opposed to one another along the lengthwise axis. Asshown, the two actuating elements 152 define an outer diameter having adimension that is larger than the diameter of the nose section 430.

In an example, the actuating elements 152 are flexible and deflectableso that when pushed by a male Luer tip, the actuating elements defect orflex. The actuating elements are deflectable by selecting a materialthat has the requisite resilient properties. In other examples, theactuating elements are deflectable by incorporating one or more weakenedsections, such as by incorporating a structurally thin section, byincorporating cut-outs, by employing a small cross-section compared toother sections of the same elongated actuating element, or combinationsthereof. Alternatively, the actuating elements 152 can be flexible anddeflectable by selecting a material that has the requisite resilientproperties and by incorporating one or more weakened sections.

In still other examples, each actuating element 152 has more than onedifferent cross-sectional profiles or contour along a length section.For example, an elongated plunger element can have a square profilelocated adjacent a crescent-shaped profile.

In an example, the actuating elements 152 are rigid and not deflectableor deformable when loaded, such as when pushed, by a male Luer tip.Further, stabilizing elements may be incorporated to increase therigidity of the two actuating elements 152. The two actuating elements152 may each include a cross-sectional profile, at least at a proximalend, that overlaps a push end of a male tip so that the male tip canpush the valve actuator into the valve, as previously discussed withreference to FIGS. 5C and 5D.

The nose section 430 of the valve actuator 134 can be configured toengage the valve 136 to open the valve disc 410 when an axial force isapplied by a male tip to the actuating elements 152 towards the distalend of the catheter assembly 100, such as during the insertion of an IVdrip line male Luer connector. Generally, the nose section 430 is rigidrelative to the more pliable valve 136, which allows the nose section430, and more specifically the actuation end 436, to actuate the valve136, such as to deflect the one or more flaps and open the one or moreslits on the valve disc 410. The nose section 430 may be made of anon-compressible material, such as metal, a rigid plastic, or a hardelastomer for pushing against and opening the valve. The illustratedvalve actuator embodiment 134 includes a pair of opposed bands orstabilizers 444, 444 (collectively or individually referred to asstabilizer or stabilizers 444) connecting the two actuating elements 152at a location along the length of the actuating elements that arebetween the nose section 133 and the proximal end of the actuatingelements. In some examples, the stabilizers 444 can be located at theproximal end of the two actuating elements 152 so that proximal edges ofthe stabilizers 444 are generally flush with the proximal end surfacesof the actuating elements. The two stabilizer elements 444, 444 can bereferred to as a first or upper stabilizer element and a second or lowerstabilizer element.

In one embodiment, the stabilizers or stabilizer elements 444, 444 arearc-shaped, forming an arc following the interior profile of thecatheter hub 102 and connecting one actuating element 152 to anotheractuating element 152. The stabilizers or stabilizer elements 444 mayform a substantially cylindrical section on the body of the valveactuator, which body is spaced apart from the nose section 430 of thevalve actuator. In other words, the valve actuator can be elongated andcan have sections that are continuous along a radial direction andsections with reliefs or through passages through the wall of theactuator that are not continuous along the radial direction.

In an example, the stabilizers 444 define a continuous body sectionalong a perimeter or radial direction of the valve actuator that isspaced from a continuous body section of the nose section 430, which isalso continuous along a perimeter or radial direction. The twostabilizers or stabilizer elements 444, 444 may be joined together withthe two plunger elements 152 to form a ring structure. Optionally, thetwo stabilizers may be slightly offset and angled from each other, asshown in FIG. 10a . In some embodiments, there may be one, three, or adifferent number of actuating elements 152 or stabilizers 444. In anexample, the valve actuator 134, with the stabilizers or stabilizerelements 444 and projections 442, is made from plastic, such as byplastic injection molding.

The stabilizers 444 can help the valve actuator 134 remain centeredwithin the catheter hub 102 while the actuator moves, such as whenpushed by a male Luer tip. By staying centered, the nose section 430 canbe better aligned with the valve disc 410, such as the slits on thevalve disc, allowing for smooth actuation of the valve 136. Thestabilizers 444 can also provide an engagement, via friction, with theinterior of the catheter hub 102 to prevent the actuator 134 fromsliding in the proximal direction following removal of the male Luertip.

In one embodiment, the nose section 430 is configured to remain engagedto the valve disc 410 following actuation of the valve and followingremoval of the male Luer tip. For example, the nose section 430 canwedge between the one or more slits on the valve disc and be held thereby friction, as further discussed below. Surface features, such asbumps, grooves, or barbs, can be provided on the valve actuator 134,such as on the nose section, to maintain the engagement between theactuator and the valve following actuation and following removal of themale Luer tip.

A relief, opening, or through passage 448 is provided between thetransition section 440, or from the nose section, and each of the twostabilizers 444, 444. The two reliefs or through passages 448 provideclearance so that the interior or central part of the valve actuator 134and the interior surface of the catheter hub 102 can be in opencommunication. In other words, between the continuous section of thenose section and the continuous perimeter section defined by the twostabilizers 444, 444 and the plunger elements 152, call a stabilizingring or stabilizing ring 456 (FIG. 12A), are one or two reliefs, throughpassages, or openings 448.

The stabilizing ring 456 of the valve actuator 134 can have an insidediameter that is smaller than the diameter defined by the diagonalsection or elbows 304 of the two arms 288, 290 of the needle guard 132when the two arms are biased outwardly by the side of the needle shaft.Thus, during installation of the needle guard 132 into the holding spaceof the valve actuator 134, the diagonal section or elbows of needleguard 132 can deflect to pass through the stabilizing ring 456 and intothe open areas defined by the reliefs 448.

When the tip protector 132 is positioned between the two plungerelements 152, the two distal walls 300, 302 (FIG. 7) of the needle guard132, more specifically the two diagonal sections or elbows 304, can belocated in the reliefs 448 as discussed above to engage the guardengagement surface on the interior surface of the catheter hub 102. Thisallows the needle guard 132 to project from the holding space of thevalve actuator 134 through the two reliefs 448 to engage with the guardengagement surface of the catheter hub. The needle guard can thereforebe retained within the interior of the catheter hub in the ready to useposition and during retraction of the needle following successfulvenipuncture until the needle tip moves proximal of the two distal wallson the needle guard, at which time the needle guard can close over theneedle tip and be removed with the needle as discussed above withreference to FIG. 3.

A second undercut or recessed section 450 proximal of the first recessedsection 420 can be provided in the interior cavity of the catheter hub102 for accommodating the two diagonal sections or elbows 304. Theneedle guard 132 can therefore be prevented from sliding in the proximaldirection during retraction of the needle following successfulvenipuncture by a shoulder 452 of the second recessed section 450 or bysome other surface feature on the interior of the catheter hub, such asa guard engagement surface on the interior of the catheter hub.Optionally or alternatively, the distal edge 446 a (FIG. 12B) of one orboth stabilizers 444, 444 can provide the restraining surface to preventthe needle guard 132 from early activation during retraction of theneedle, prior to the needle tip moving proximally of the two distalwalls 300, 302. In addition to the distal edge 446 a, both stabilizers444, 444 also have a proximal edge 446 b.

In some examples, one or both stabilizer elements 444, 444 can have aslit or a channel, thus dividing that arc-shaped stabilizing elementinto two segments, similar to the stabilizer elements of FIGS. 16A-16C.Nonetheless, even with a slit on one or both stabilizer elements 444,444, the stabilizing ring 456, which can be a non-continuous ring,similar to a ring with one or more slots formed through the ring, canstill provide the restraining surface to prevent the needle guard 132from early activation during retraction of the needle, prior to theneedle tip moving proximally of the two distal walls 300, 302 (FIG. 7).The restraining surface can also be referred to as a restrict point,choke gap, or choke point since it provides a rigid structure thatprevents the needle guard from moving proximally thereof unless or untilthe needle guard first activates and collapses radially to reduce itsradial profile to then slip proximally of the choke point. In anexample, one or two elbows 304 (FIG. 7) of the needle guard can berestricted by the choke point from moving in the proximal directionuntil the one or two elbows of the needle guard deflect to reduce needleguard's radial profile. In an example, when the radial profile of theneedle guard is reduced, the needle guard can slip through the boredefined by the stabilizing ring, from a distal position of thestabilizing ring to a proximal position of the stabilizing ring.

With further reference to FIG. 10B, which is the top cross sectionalview of the same catheter assembly 400 of FIG. 10A rotated 90 degreesfrom the FIG. 10A view, with the tip protector 132 shown fitting betweenthe actuating elements 152. In an embodiment, one or more actuatingelements 152 are sized and shaped for contact by a male Luer to transfera distally directed force from the male Luer, through the nose 430 tothen open the valve 136, as previously discussed.

The valve opener 134 can be made from a metal material or from a plasticmaterial. When made from a metal material, the valve opener 134 can beformed by bending or deep draw methods and the arc shape cross sectionof the actuating element 152 can provide added rigidity when pushed bythe male Luer. Each actuating element 152 can comprise at least twolengthwise edges and a rib can be provided along one or both of thelengthwise edges to further add structural rigidity. One or more gapscan be provided between any two actuating elements 152. The gaps canprovide clearance or space for fluid flow flowing thereacross, such asduring flushing blood or IV infusion. The gap between the actuatingelements 152 can define a holding space to accommodate a tip protector132, as shown in FIG. 10B.

In some embodiments, a majority or most if not all of the tip protector132 fits within a holding space formed by the body of the actuator 134,between the two plunger elements 152, in the ready to use position, asshown in FIG. 10B. This allows the catheter hub 102 to be more compact,as less longitudinal space is needed within the hub to fit both theactuator 134 and the tip protector 132 serially lengthwise or when thetwo only partially overlap in the axial direction. In FIG. 10B, the tipprotector 132 is shown fitting completely within the holding space ofthe actuator 134 to further reduce the needed space or length in thecatheter hub. As shown, the proximal wall 280 of the needle guard 132 isgenerally flush or even with the proximal end surfaces of the twoplunger elements 152.

When the tip protector 132 only engages with the distal edge 446 a ofthe relief or through passage 448 in the actuator, then no deformity orchange of diameter is required on the inside wall of the catheter huband the tip protector 132 can be placed further proximally in the femaleLuer taper section while complying with the international Luer standardfor conical fittings and the overall length of the catheter hub 102 canbe further reduced.

FIG. 11 is a perspective view of the catheter assembly 400 of FIGS. 10Aand 10B. The relief or through passage 448 is clearly shown proximal tothe nose section 430 of the actuator 134 to allow the tip protector 132to engage with the interior of the catheter hub 102, as previouslydiscussed. Proximal to the relief 448, a stabilizer 444 can be seen toprovide additional rigidity and/or a greater engagement surface for thecatheter hub 102. The actuating elements 152 extend past the proximaledge 446 b (FIGS. 12A and 12B) of the stabilizer 444 to substantiallythe same distance as the proximal wall 280 of the tip protector 132. Inthe illustrated embodiment, the tip protector 132 substantially fitswithin the holding space of the actuator 134 and the proximal wall 280of the tip protector is approximately even with the proximal ends of theactuating elements 152, in the axial direction.

FIG. 12A is a partial cross-sectional side view of the valve assembly400 after the needle and needle guard have been removed from thecatheter hub 102, such as following a successful venipuncture. As shown,the valve 136 is in a closed position in which the one or more slits 324of the valve disc 410 are closed. Also shown is the valve actuator 134retracted position in which the actuation end 436 of the nose section430 is not pushed into and opening the one or more slits. This positionis also understood to be the valve pre-activated position. That is, amale Luer tip has not been inserted into the proximal opening of thecatheter hub to advance the valve actuator to open the valve. In otherwords this is the valve closed position.

FIG. 12B is a partial cross-sectional side view of the valve assembly400 of FIG. 12A in which the valve has been actuated to open the one ormore slits 324. The present view shows the valve actuator 134 advanceddistally into the valve 136 by a syringe tip or a Luer tip of an IV dripline (not shown) to permit fluid flow through the catheter hub.Advancing the actuator 134 causes the actuation end 436 to advanceagainst the valve disc 410 and deflecting the flaps radially anddistally to open a fluid path to be formed through the catheter assembly400.

When initially inserting the male medical implement, such as a male Luertip, into the proximal opening of the catheter hub 102, the male tipinitially contacts the two actuating elements 152 on the actuator 134 toadvance a distally directed force on the two actuating elements 152 toopen the valve 136. The distally directed force moves the actuator 134in the distal direction until the geometries of the male tip and theproximal opening of the catheter hub stop further distal advancement ofthe male tip. In an example, a female Luer taper of the catheter hub 102and a male Luer taper of the male tip mate and block distal advancementof the male tip further into the opening of the catheter hub. A seal isprovided by the Luer engagement to prevent fluid from leaking out theproximal opening of the catheter hub.

As the actuator 134 moves distally by the distal advancement of the maletip, the nose 430 of the valve actuator 134 is urged distally and pushesagainst the proximally facing surface of the valve disc 410. Inparticular, the nose of the actuator 134 initially pushes against theproximally facing surface of the valve disc 410 and since the valve isaxially fixed within the first recessed section 420 of the catheter hub,the one or more flaps on the valve disc 410 deflect radially and in thedistal direction. Fluid from the male tip can then flow through thecatheter hub 102, through the valve 136, and through the lumen of thecatheter tube 104.

Alternatively, a suction can be applied by the male medical instrument,such as a syringe or vacuum blood collection tube, and blood aspiratedfrom the patient. This is often done for testing samples before infusiontherapy is commenced. Also, typically any remaining blood is firstflushed from the inside of the catheter hub 102 before infusion therapyis commenced.

With continued reference to FIG. 12B, the actuation end 436 of the nosesection 430 is shown projected through the valve disc 410 and eithercontacts or is just about to contact the bushing 138 in the valveactuated position. In this configuration, even after removal of the maletip, the valve actuator 134 remains engaged to the valve 136. That is,the friction between the valve actuator 134 and the valve disc 410exceeds the restoring forces produced by the valve flaps in attemptingto return to its un-deformed position shown in FIG. 12A. This activatedpositon can be considered a one-time use or one-time actuation since thevalve actuator 134 and valve 136 do not return to the pre-activationposition of FIG. 12A when the male tip is removed.

In an alternative embodiment, the nose section 430 is configured so thatwhen pushed into the valve 136 during activation, the actuation oractivation end 436 does not extend distally past the flaps of the valvedisc 410. This configuration can ensure that the valve actuator 134 ispushed back by the flaps of the valve disc when the male Luer implementis removed. A conical configuration at the distal end of the actuator134 can be such a configuration, which maintains a proximally directedforce vector, which is greater than a perpendicular force vector. Theangle of the cone can be designed to provide the necessary force vectorswhen the actuator 134 has reached it maximum distal movement and itsminimum distal movement. The difference between the maximum movement andminimum movement of a standard Luer connector is approximately 2.5millimeters.

Additionally, a spring or an elastic element or ring, similar to theresilient element 276 of FIG. 1, can be incorporated at the distalcavity chamber 130 a to increase the re-coil or returning forces of thevalve 136 to facilitate pushing the valve actuator 134 in the proximaldirection following removal of the male tip to return to thepre-activated position or valve closed position shown in FIG. 12A. Theelastic element can also help to close the flaps of the valve disc 410.In this manner, the valve 136 and valve actuator 134 can be re-closedafter the initial activation and re-open and so forth, repeatedly.Alternatively or additionally, the flaps 326 on the valve disc can bemade thicker to provide enough restoring force without the need for anelastic element.

With reference again to the stabilizing ring 456 of FIGS. 12A and 12B,note that the distal edge 446 a and the proximal edge 446 b on thestabilizers 444, 444 are not parallel to the proximal edge of the twoplunger elements 152. Instead, the distal edge 446 a and the proximaledge 446 b of the upper stabilizer 444 are parallel to each other andthe distal edge 446 a and the proximal edge 446 b of the lowerstabilizer 444 are parallel to each other but the corresponding edges ofthe upper and lower stabilizers 444, 444 are not parallel to oneanother. Said differently, the upper stabilizer 444 has a distal tiltwhile the lower stabilizer 444 has a proximal tilt.

FIG. 13A is a perspective view of a valve actuator 134 embodimentprovided in accordance to further aspects of the present disclosure. Theactuator 134 comprises a generally cylindrical nose or nose section 430,such as a conical frustum shape nose, and an activation end 436 at adistal end thereof. Actuating arms 152 extend lengthwise from the nosesection 430. The valve actuator 134 provides similar functionally as theactuator 134 of FIGS. 1-4 and 10A-12B, with some structural differences,such as the stabilizers 444 being generally even without off-settingedges. In the ready position and if used with the catheter assembly ofFIGS. 10A and 10B, the nose section 430 may be in contact with the valvedisc or can be slightly spaced from the proximal surface of the valvedisc 410.

A relief or through passage 448 provides access for a tip protector 132to engage with the interior of the catheter hub 102, as previouslydescribed. In one embodiment, two through passages or reliefs 448 onopposite sides of the body of the actuator 134 are provided to giveaccess to the interior of the catheter hub 102 to two corresponding armsof a tip protector 132. Other embodiments can have a different number ofthrough passages, such as one, three or more, can be incorporated. Forexample, there may be three through passages spaced between threeactuating elements. The distal end of the relief or through passage 448forms an engagement shoulder 550 for a valve arm, which is discussed infurther detail in FIGS. 14B and 14C.

In the illustrated embodiment, the stabilizers 444 connect the twoactuating elements 152 and form a ring structure on the proximal end ofthe actuator 134, also called a stabilizing ring 456. The stabilizers444 can provide additional rigidity and/or engagement surfaces for theactuator to interact with a needle guard and/or with the interior of thecatheter hub 102. In some embodiments, the stabilizing ring 456comprises one, two, or more individual sections that form asubstantially cylindrical section of the actuator body. The stabilizerscan have edges that align with each other or may be offset, such asshown in the embodiment of FIG. 10A.

FIGS. 13B and 13C illustrate a side and top view of the actuatorembodiment 134 of FIG. 13A. A majority of the tip protector 132 is shownfitted inside the holding space of the actuator 134, with a portion ofthe tip protector extending in the proximal direction past the proximalend of the actuator. For example, the proximal wall 280 and part of thetwo arms 288, 290 of the tip protector 132 extend radially through therelief 448 of the actuator 134. One or more ribs or projections 552 canbe formed on the exterior surface of the actuating arms 152 and canengage with a shoulder 452 on the second recessed section 450 (FIG. 10A)of the catheter hub to retain the actuator 134 inside the catheter hub102 in the ready to use position and used position.

FIG. 14A illustrates a valve embodiment 136 having one or more ridges602 formed on the outer surface of the valve skirt 412. FIG. 14Billustrates the valve 136 of FIG. 14A, connected to the actuator 134 ofFIGS. 13A-13C, while in a ready position in a catheter hub 102.

The valve 136 of FIG. 14A performs a similar function as the valve 136of FIGS. 1, 10A-10B, and 12A-12B and has many of the same structures,such as a skirt, 412, a valve disc 410, and valve slit 324. The valve136 further includes a distal skirt section 413 extending distally ofthe valve disc 410. In addition, an engagement surface 602, such as oneor more ridges, is formed on the outer surface to provide greaterengagement with the catheter hub 102, as shown in FIG. 14B.

The engagement surface 602 can comprise a projection or a groove or acombination of both a groove and a projection formed on the exteriorsurface of the valve 136. For example, the engagement surface 602 maycomprise a section having a first outer diameter (e.g., peak/projection)and a second outer diameter (e.g., valley/groove), with the sectionsrepeated one or more times on the outer perimeter of the valve. Inanother example, the grooves and/or projections may be formed as asingle continuous, spiral structure on the exterior of the valve.

In some embodiments, the engagement surface 602 extendscircumferentially along the outer surface of the valve 136, formingrings or a spiral thread. In other embodiments, the engagement surface602 comprises several separate sections formed on the outer surface,such as separate protrusions/recesses or the thread sections on aninterrupted screw.

The catheter hub 102 may be provided with a corresponding engagementsurface 610 on the interior surface of the catheter hub to mate with thevalve engagement surface 602 of the valve 136. The engagement surface610 can be similar to the engagement surface 602 of the valve 136, butwith inverse features in order to mate with the valve engagement surface610.

By forming engagement surfaces on the valve 136 and the catheter hub102, the valve can be better retained in the correct position in thecatheter hub 102, even as the actuator 134 applies force to the valve136. The valve 136, with the engagement surface 602, can be axiallyfixed within the catheter hub without a recessed section having proximaland distal shoulders.

In the illustrated embodiment, two engagement arms 612 are formed on theproximal end of the valve 136, extending radially inwards from theinterior surface of the valve skirt 412. The engagement arms 612 areconfigured to mate with the engagement shoulders 550 formed on theactuator 134. In the illustrated embodiment, two opposing engagementshoulders 550 are configured to engage with the two engagement shoulders550 formed by the two reliefs or through passages 448 in the actuator134. In other embodiments, different numbers of engagement shoulders andengagement arms may be used (e.g., one, three, or more).

Referring to FIG. 14B, in a ready position, the nose 430 of the actuator134 lies within a holding space 620 of the valve 136, adjacent to theproximal surface of the valve disc 410. The valve skirt 412 surroundsthe nose 430, with the engagement arms 612 partially extending into thereliefs or through passages 448 of the actuator and engaging with theengagement shoulders 550. In one embodiment, the engagement arms 612have a sufficiently low profile to not interfere with the needle and thetip protector 132, such that the arms 612 do not interfere with themovement of the needle and the tip protector 132.

FIG. 14C is a perspective cut-away view of the needle assembly of FIG.14B.

The valve 136 of the catheter assembly 600 of FIGS. 14B and 14C may beconfigured as a one-time or single actuation use. Optionally, the valvedisc 410 of the valve 136 may be made sufficiently resilient such as bymaking the flaps thicker so as to return to its closed position after amale Luer tip is removed and an axial load is no longer applied to thevalve actuator. In another example, an elastic element, similar toresilient element 276 of FIG. 1, may be incorporated to assist withclosing the flaps on the valve. The actuator has a conical nose, whichis preferred for a multi-use valve design. The conical shape when notpushed further than the distal ends of the open flaps will retain aproximally directed force vector of the flap against the conicalsurface, which can push the actuator back to its starting position untilthe flaps are closed again and flow is stopped.

With reference now to FIG. 15A, a top or plan view of a valve opener oractuator 134 is shown. The valve opener can be used with any needleassembly described elsewhere herein, such as shown in FIGS. 9-12B. Asshown, the valve actuator has a nose section 430, a transition section440, and two plunger elements 152 extending proximally of the transitionsection, or proximally from the nose section. The nose section 430defines a first continuous perimeter section 700. Other locations of thenose section 430, away from the first continuous perimeter section 700,can comprise a slit or a slot.

Two stabilizer elements 444, 444 are attached to the two plungerelements 152 to form a stabilizing ring 456, which defines a secondcontinuous perimeter section 702 of the valve actuator. Each stabilizerelement 444 can comprise two edges 446 a, 446 b. In an example, the twoedges 446 a, 446 b of each stabilizer element can be parallel to oneanother. As shown, the two stabilizer elements 444, 444 are skewed orslanted so that while two edges 446 a, 446 b of each stabilizer elementcan be parallel to one another, the two edges 446 a, 446 b from onestabilizer element are not parallel to the two edges 446 a, 446 b of theother stabilizer element. As shown, the proximal edges 446 b of the twostabilizer elements 444, 444 are offset along an axial direction orlengthwise direction of the valve actuator. As shown, the distal edges446 a of the two stabilizer elements 444, 444 are offset along an axialdirection.

Two reliefs or two through passages 448 are provided on the valve opener134, each defined or bounded by the transition section 440, the twoplunger elements 152, and the respective stabilizer elements 444, 444.The two reliefs or through passages may be referred to as a first reliefor first through passage and a second relief or second through passage.In an example, each relief or through passage has a perimeter 708. In anexample, each perimeter can be defined by the structure of thetransition section 440, the two plunger elements 152, and the respectivestabilizer elements 444, 444. As the two stabilizer elements 444, 444can skew or slant in different directions, the two perimeters 708 of thetwo reliefs or through passages 448 can be different, such as havingdifferent perimeter contours or shapes. As shown, the two perimeters 708are each defined by a continuous loop. In other words, in the presentembodiment, the perimeters 708 do not have a slit or a slot to form anopen perimeter. However, where a stabilizer element 444 includes a slotor a slit, the perimeter can be an open perimeter or a non-continuousperimeter.

In some examples, the two stabilizer elements 444, 444 can extendlaterally without skewing or slanting in the distal direction or theproximal direction. When so configured, the edges 446 a, 446 b of thetwo stabilizer elements 444, 444 are parallel to one another.Additionally, the four edges of the two stabilizer elements can beparallel to one another and axially offset. That is, the proximal edge446 b of one stabilizer element can be located more proximally ordistally that the proximal edge 446 b of the other stabilizer elementwhile the four edges are parallel to one another.

With further reference to FIG. 15A, two plunger element stubs orextensions 152 a are shown extending proximally of the stabilizing ring456. In an example the two plunger element stubs 152 a can extend fromthe stabilizing ring 456 and axially align with the plunger elements 152located distally of the stabilizing ring 456. In other examples, the twoplunger element stubs 152 a are not axially aligned with the two plungerelements 152 located distally of the stabilizing ring 456. In stillother examples, only one plunger element stub 152 a aligns with one ofthe two plunger elements 152. For a valve opener or actuator with onlyone plunger element 152 between the first and second continuousperimeter sections, only one of the two plunger element stubs 152 a ornone of the plunger element stubs can align with the one plungerelement.

In some examples, there can be more than two plunger element stubs orextensions 152 a extending proximally of the stabilizing ring 456. Thetwo or more plunger element stubs or extensions 152 a can be equallyspaced around the proximal periphery of the stabilizing ring 456 orrandomly spaced around the proximal periphery of the stabilizing ring456. The plunger element stubs can extend the overall length of a valveactuator. The number of plunger element stubs and/or the arc-curve ofeach plunger element stub, which defines a width of each plunger elementstub, can provide a greater overlapping surface with a male Luer tipthan fewer numbers or for a plunger element stub with a relativelysmaller arc-curve.

With still further reference to FIG. 15A, the two plunger elements 152are each shown with at least two thicknesses to create a projection 442at an interface between the two thicknesses on an outside surface 710 ofeach plunger element. As previously described, the two projections 442can be located inside a recessed section 450 (FIG. 10B) so that ashoulder 452 at a proximal end of the recessed section 450 can provide astop surface to prevent dislodgement of the valve opener 134 in theproximal direction. In some examples, only one projection 442 isemployed on one of the two plunger elements to prevent dislodgement ofthe valve opener 134 in the proximal direction. In still other exampleseach plunger element 152 has a single thickness and the projection 442is formed by adding material to the plunger element during injectionmolding at the site of the projection only.

In an example, a planar surface section 714 is provided with the valveactuator 134 on the same side of each stabilizer element 444. The planarsurface section 714 originates from about the nose section 430 or thetransition section 440 of the valve member and extends proximally toabout the two projections 442.

With reference now to FIG. 15B, which is a cross-sectional side view ofthe valve opener 134 of FIG. 15A taken along lines 15B-15B, the twoplanar surface sections 714, one on each side of the valve opener 134corresponding to the two stabilizer elements 444, are provided as a wayto minimize the overall profile of the transition section 440 and thetwo plunger elements 152 along a side profile, as shown in 15B. Thus, inan example, the cross-sectional dimension of the nose section 430, ofthe transition section 440, and of the two plunger elements 152 aregenerally constant or be the same within typical manufacturingtolerances along a side view, or a 90 degree turn along the lengthwiseaxis of the valve opener from the orientation of FIG. 15A.

With continued reference to FIG. 15B, a holding space 720 is shown,which can be located between two plunger elements 152, inside thestabilizing ring 456, between two plunger element stubs 152 a, orcombinations thereof. As previously described, part or all of a needleguard or tip protector 132 can be located in the holding space 720 in aready to use position and one or two elbows of the tip protector 132projecting out the relief 448.

A proximal wall of a needle guard 132 can be flush with the proximal endsurface 726 of a plunger element stub 152 a, located proximally of theend surface 726, or located distally of the end surface. If no plungerelement stub is incorporated, a proximal wall of a needle guard 132 canbe flush with the proximal edge of one or both stabilizer elements 444,444, located proximally of the proximal edge of one or both stabilizerelements 444, 444, or located distally of the proximal edge of one orboth stabilizer elements 444, 444.

With still further reference to FIG. 15B, the distance between the twoinside surfaces 728 of the two stabilizer elements 444, 444 define achoke gap, choke point, or restricting point for a needle guard to limitproximal movement of the needle guard in a ready to use position and/orduring retraction of the needle following intravenous access, aspreviously discussed. That is, before the needle tip moves proximally ofone or two distal blocking walls of a needle guard, the choke point orgap is too small for the needle guard to pass proximally of the chokingpoint, choke point, or restricting point. However, after the needle tipmoves proximally of one or two distal blocking walls of the needleguard, the two distal walls move radially inwardly to decrease theneedle guard's radial profile, which is smaller than the choke point. Atthat point, with a smaller radial profile measured at two elbows, theneedle guard can move proximally of the choke point.

FIG. 15C is a perspective view of the valve opener 134 of FIGS. 15A and15B.

With reference now to FIG. 16A, a top or plan view of a valve opener oractuator 134 in accordance to an alternative aspect of the presentdisclosure is shown. The valve opener 134 can be used with any of theneedle assemblies disclosed elsewhere herein. As shown, the valveactuator has a nose section 430, a transition section 440, and twoplunger elements 152 extending proximally of the transition section 440.The nose section 430 defines a first continuous perimeter section 800.Other locations of the nose section 430, away from the first continuousperimeter section 800, can comprise a slit or a slot.

Two stabilizer elements 444, 444 (FIG. 16B) are attached to the twoplunger elements 152 to form a stabilizing ring 456. However, eachstabilizer element 444, 444 is non-continuous and has a slit or slot804. Said differently, each stabilizer element 444 of the presentembodiment comprises two stabilizer segments 810, 812 spaced from oneanother by a slit or slot 804. Each stabilizer segment 810 is furtherunderstood to include an inside edge 814 that is spaced from the otherinside edge 814 of the other stabilizer segment 812. The two insideedges 814 define a slit or a slot 804 therebetween. The two stabilizersegments 810, 812 can be similar or the same or can be different.

The width of the slit or slot 804 is smaller than the widest width ofthe needle guard 132 (FIG. 7). In some examples, the width of the slitor slot 804 is smaller than the width of the distal walls 300, 302. Thewidth of the slit or slot can also be smaller than the width of theneedle guard at the elbows 304. The relative dimensions between the slitor slot 804 on the valve opener 134 and the width of the needle guard132 are selected so that the stabilizing rings 456 are sized to limitproximal movement of the needle guard 132, such as the two elbows 304 onthe needle guard, from moving proximally of the stabilizing ring duringretraction of the needle but before activation of the needle guard. Inother words, even with slits or slots incorporated with the twostabilizing rings, they can still act as restraining surfaces or chokepoints.

As noted previously, the valve opener 134 can incorporate one or twostabilizer elements 444. The one or two stabilizer elements 444 can alsobe continuous or be segmented having slits or slots 804 between thesegments. A needle guard with one arm and one elbow, two arms but onlyone elbow, or two arms and two elbows can be used with any of thevarious valve actuators.

While the stabilizing ring 456 of the present valve embodiment comprisesone or more slits, such as two slits 804, the stabilizing ring 456provides similar restrictions or choke points along the two stabilizerelements 444, 444 for a needle guard or tip protector as other valveactuators 134 described elsewhere herein, and as further discussedbelow. The stabilizing ring 456, which has a non-continuous perimetersection, can also provide stability during axial movement of the valveactuator 134 by acting as a bearing to guide the valve actuator 134against the interior surface of a catheter hub.

Each stabilizer element 444 can comprise two non-continuous edges 446 a,446 b, which can be referred to as a distal edge 446 a and a proximaledge 446 b. In an example, the two edges 446 a, 446 b of each stabilizerelement are parallel to one another. The two edges 446 a, 446 b from onestabilizer element 444 are also parallel to the two edges 446 a, 446 bof the other stabilizer element. As shown, the proximal edges 446 b ofthe two stabilizer elements 444, 444 are aligned along an axialdirection or lengthwise direction of the valve actuator. As shown, thedistal edges 446 a of the two stabilizer elements 444, 444 are alsoaligned along an axial direction. In other examples, the edges of thetwo stabilizer elements 444 can be offset axially.

Two reliefs or two through passages 448 are provided on the valve opener134, each defined or bounded by the transition section 440, the twoplunger elements 152, and the respective stabilizer elements 444, 444.The two reliefs or through passages 448 may be referred to as a firstrelief or first through passage and a second relief or second throughpassage. In an example, each relief or through passage has a perimeter820. In an example, each perimeter 820 can be defined by the structureof the transition section 440, the two plunger elements 152, and therespective stabilizer elements 444, 444. The two perimeters 820 of thetwo reliefs or through passages 448 can be the same, as shown, or canhave different perimeter contours or shapes. Because of the slits orslots 804, one on each stabilizer element 444, the two perimeters 820are open, such as being non-continuous.

The valve opener 134 of the present embodiment can be made from a metalmaterial. For example, a stamped metal sheet, such as a stampedstainless steel sheet, can be worked using deep draw methods to form theshape shown. The various openings or gaps can be punched or stamped andthen cold worked to form the disclosed shaped. Each plunger element 152comprises at least two lengthwise edges and a rib can be provided alongone or both of the lengthwise edges to further add structural rigidity.One or more gaps 154 can be provided between any two plunger elements152. The gaps 154 can provide clearance or space for fluid flow flowingthereacross, such as during IV infusion. The gap 154 can also beutilized to accommodate a needle guard 132, as shown in FIG. 1.

With further reference to FIG. 16A, two plunger element stubs orextensions 152 a are shown extending proximally of the stabilizing ring456. In an example the two plunger element stubs 152 a can extend fromthe stabilizing ring 456 and axially align with the plunger elements 152located distally of the stabilizing ring 456. In other examples, the twoplunger element stubs 152 a are not axially aligned with the two plungerelements 152 located distally of the stabilizing ring 456. In stillother examples, only one plunger element stub 152 a aligns with one ofthe two plunger elements 152.

In some examples, the valve opener 134 terminates at the stabilizingring 456 and the actuator is without any plunger element stubs 152 a. Instill other examples, each plunger element stub 152 a located proximallyof each plunger element can be considered part of the same plungerelement and the stabilizer segments 810, 812 are tabs extending radiallyfrom the two lengthwise edges of the two plunger elements 152 at alocation distal of the proximal surface 824.

In some examples, there can be more than two plunger element stubs orextensions 152 a extending proximally of the stabilizing ring 456. Thetwo or more plunger element stubs or extensions 152 a can be equallyspaced around the proximal periphery of the stabilizing ring 456 orrandomly spaced around the proximal periphery of the stabilizing ring456. The plunger element stubs can extend the overall length of a valveactuator 134. The number of plunger element stubs and/or the arc-curveof each plunger element stub, which defines a width of each plungerelement stub, can provide a greater overlapping surface with a male Luertip than fewer numbers or for a plunger element stub with a relativelysmaller arc-curve. In some examples, the plunger elements stubs 152 ahave curved profiles that can resemble that of the plunger elements ofFIGS. 5C and 5D, wherein the concave and convex surfaces of the plungerelements can face in either direction, inwards or outwards relative tothe lengthwise axis of the valve actuator.

With still further reference to FIG. 16A, the two plunger elements 152each comprises a projection 442 on an outside surface 826 of eachplunger element. As previously described, the two projections 442 can belocated inside a recessed section 450 (FIG. 10B) of a catheter hub sothat a shoulder 452 at a proximal end of the recessed section 450 canprovide a stop surface to prevent dislodgement of the valve opener 134in the proximal direction. In some examples, only one projection 442 isemployed on one of the two plunger elements 152 to prevent dislodgementof the valve opener 134 in the proximal direction. In an example, eachprojection 442 can be formed by cold-working a surface of the stampedmetal sheet at the respective plunger element to push out a protrudingsurface.

With reference now to FIG. 16B, which is a cross-sectional side view ofthe valve opener 134 of FIG. 16A taken along lines 16B-16B, the nosesection 430 is shown with a tapered extending in a proximal directionand into a transition section 440. The two plunger elements 152 arenecked down from the transition section with two radiused sections 830.Each plunger element 152 extends in the proximal direction with agenerally constant width and then necks up with a second set of radiusedsections 832, which transition into the stabilizer segments 810, 812. Arecessed surface forming one of the projections 442 is shown on theplunger element 152.

Another pair of radiused sections 834 are located proximally of thestabilizer segments 810, 812 to form the plunger element stub 152 a. Theplunger elements 152 and the plunger element stubs 152 a both have twospaced apart lengthwise edges, which can be provided with ribs to addstrength to the respective structure. From within the stabilizing ring456 and extending in a proximal direction, each plunger element stub 152a is cold-work to form outwardly bulging portions 838 relative to thelengthwise axis to form curved surfaces along the cross-section of eachstub 152 a. The bulging portions 838 can also be formed inwardly to forminward bulging portions. This feature can be included to form theconcave and convex surfaces for the plunger element stubs, as previouslydiscussed.

With continued reference to FIG. 16B, a holding space 842 is shown,which can be between two plunger elements 152, inside the stabilizingring 456, between two plunger element stubs 152 a, or combinationsthereof. As previously described, part or all of a needle guard or tipprotector 132 can be located in the holding space 842 in a ready to useposition and one or two elbows of the tip protector 132 can project outthe reliefs 448.

A proximal wall of a needle guard 132 can be flush with the proximal endsurface 824 of a plunger element stub 152 a, located proximally of theend surface 824, or located distally of the end surface. If no plungerelement stub is incorporated, a proximal wall of a needle guard 132 canbe flush with the proximal edge 446 b of one or both stabilizer elements444, 444, located proximally of the proximal edge 446 b of one or bothstabilizer elements 444, 444, or located distally of the proximal edge446 b of one or both stabilizer elements 444, 444.

With still further reference to FIG. 16B, the distance between the twoinside surfaces 850 of the two stabilizer elements 444, 444 define arestricting point, a choke gap or a choke point for a needle guard tolimit proximal movement of the needle guard in a ready to use positionand/or during retraction of the needle following intravenous access, aspreviously discussed. That is, before the needle tip moves proximally ofone or two distal blocking walls of a needle guard, the choke point orgap is too small for the needle guard to pass proximally of the chokepoint. However, after the needle tip moves proximally of one or twodistal blocking walls of the needle guard, the two distal walls moveradially inwardly to decrease the needle guard's radial profile, whichis smaller than the choke point. At that point, with a smaller radialprofile measured at two elbows, the needle guard can move proximally ofthe choke point.

FIG. 16C is a perspective view of the valve opener 134 of FIGS. 16A and16B.

Methods of making and of using the catheter assemblies and theircomponents described elsewhere herein are within the scope of thepresent disclosure.

Although limited embodiments of catheter assemblies and their componentshave been specifically described and illustrated herein, manymodifications and variations will be apparent to those skilled in theart. For example the needle guard may be of one piece or can beintegrated from more than one piece, such as from multiple pieces.Furthermore, it is understood and contemplated that featuresspecifically discussed for one catheter assembly or for one componentmay be adopted for inclusion with another catheter assembly or anothercomponent, provided the functions are compatible. Accordingly, it is tobe understood that the catheter assemblies and their componentsconstructed according to principles of the disclosed devices, systems,and methods may be embodied other than as specifically described herein.The valve and valve opener described herein can also be used with aneedle hub by locating them inside a female Luer taper of the needlehub. The valve and valve opener can also be used in the female connectorof an infusion needle or a blood collection device or a central venouscatheter or peripherally inserted central catheter (PICC) or an arterialcatheter or a dialysis needle. In other words, the valve and valveopener can be used in any medical device intended for infusion or bodilyfluid collection with a female Luer housing or hub. The disclosure isalso defined in the following claims.

What is claimed is:
 1. A needle assembly comprising: a needle hub with aneedle having a needle tip extending from a distal end of the needlehub; a catheter tube attached to a catheter hub having a body comprisingan interior surface defining an interior cavity, the needle extendingthrough the catheter tube and the needle tip out a distal end of thecatheter tube in a ready to use position; a valve positioned in theinterior cavity of the catheter hub and in contact with an internalshoulder of the catheter hub, said valve comprising an outer perimeterand a wall having three slits defining three flaps; a valve opener sizedand shaped to open the to the three slits to open the valve, said valveopener comprising a nose section having an activation end and acontinuous perimeter section having a bore passing therethrough, twoplunger elements each having two lengthwise edges extending proximallyof the nose section, and two stabilizer elements; wherein eachstabilizer element connects to the two plunger elements so that the twostabilizer elements and the two plunger elements define a stabilizingring having a continuous surface and the stabilizing ring being spacedfrom the continuous perimeter section of the nose section by two throughpassages, which include a first through passage and a second throughpassage; a needle guard comprising a proximal wall and two resilientarms located in a holding space between the two stabilizer elements,wherein each resilient arm comprises an elbow and the needle guard hastwo resilient arms and two elbows, which include a first elbow and asecond elbow; wherein the first elbow is located in the first throughpassage and the second elbow is located in the second through passage inthe ready to use position.
 2. The needle assembly of claim 1, whereinthe valve comprises a proximally facing wall surface and wherein theactivation end of the valve opener is urged against the proximallyfacing wall surface to push the three flaps against the interior surfaceof the catheter hub in a used position.
 3. The needle assembly of claim1, wherein the first elbow is in contact with a perimeter of the firstthrough passage.
 4. The needle assembly of claim 1, wherein the firstelbow is in contact with the interior surface of the catheter hub. 5.The needle assembly of claim 1, wherein the first elbow is in contactwith a perimeter of the first through passage and the interior surfaceof the catheter hub.
 6. The needle assembly of claim 1, wherein thefirst elbow is in contact with an edge of the stabilizing ring.
 7. Theneedle assembly of claim 1, wherein the valve comprises a valve disc anda valve skirt extending in a proximal direction of the valve disc anddefining a valve cavity.
 8. The needle assembly of claim 7, wherein thesecond elbow is in contact with the interior surface of the catheterhub.
 9. The needle assembly of claim 8, wherein the nose section has afrustoconical shape.
 10. The needle assembly of claim 7, wherein thesecond elbow is in contact with a perimeter of the second throughpassage.
 11. The needle assembly of claim 1, wherein the valve openercomprises a projection extending radially of a lengthwise axis of thevalve opener, and wherein the interior surface of the catheter hubcomprises a shoulder for limiting proximal movement of the projection.12. The needle assembly of claim 11, wherein the projection is a firstprojection and wherein the valve opener comprises a second projectionspaced from the first projection.
 13. The needle assembly of claim 1,wherein the valve opener comprises a projection extending radially of alengthwise axis on an exterior surface of one of the two plungerelements.
 14. The needle assembly of claim 1, further comprising a skirtsection extending distally of the wall.
 15. The needle assembly of claim1, wherein the two stabilizer elements comprise a first stabilizerelement and a second stabilizer element, wherein the first stabilizerelement has a distal edge and the second stabilizer element has a distalend.
 16. The needle assembly of claim 15, wherein the distal edge of thefirst stabilizer element is parallel to the distal edge of the secondstabilizing element.
 17. The needle assembly of claim 16, wherein thedistal edge of the first stabilizer element is angled to the distal edgeof the second stabilizing element.
 18. The needle assembly of claim 17,further comprising a projection on each of the two plunger elements todefine two projections, wherein the two projections are located distallyof the stabilizing ring.
 19. The needle assembly of claim 1, wherein theneedle guard, the valve, and the valve opener are entirely locatedwithin the interior cavity of the catheter hub.
 20. The needle assemblyof claim 1, further comprising a protective cap having a sleeve locatedaround the catheter tube and the needle.
 21. The needle assembly ofclaim 1, further comprising a bushing wedging a proximal end of thecatheter tube against the interior surface of the catheter hub and aresilient element located inside the catheter hub between the bushingand the valve disc, and wherein the resilient element is sized andshaped to push the valve disc in a proximal direction.
 22. The needleassembly of claim 21, wherein the resilient element is an elasticelement or a spring.
 23. The needle assembly of claim 1, wherein thewall of the valve has a generally flat or smooth distally facing wallsurface.
 24. The needle assembly of claim 1, further comprising aprojection on each of the two plunger elements to define twoprojections, wherein the two projections are located distally of thestabilizing ring.
 25. A method of assembling a needle assemblycomprising: providing a catheter hub with a catheter tube having an opendistal end and a proximal end attached to the catheter hub by a bushing,said catheter hub comprising a hub body having an interior surfacedefining an interior cavity and a proximal opening; positioning a valvecomprising an outer perimeter and a wall having three slits definingthree flaps in the interior cavity and proximal of the bushing;positioning a valve opener inside the interior cavity of the catheterhub to slidably push open the valve when actuated by a male medicalimplement, said valve comprising a nose section having an activation endand a continuous perimeter section having a bore passing therethrough,two plunger elements each having two lengthwise edges extendingproximally of the nose section, and two stabilizer elements; whereineach stabilizer element connects to the two plunger elements so that thetwo stabilizer elements and the two plunger elements define astabilizing ring having a continuous surface and the stabilizing ringbeing spaced from the continuous perimeter section of the nose sectionby two through passages, which include a first through passage and asecond through passage; placing a needle guard comprising a proximalwall and two resilient arms in a holding space between the twostabilizer elements, wherein each resilient arm comprises an elbow andthe needle guard has two resilient arms and two elbows, which include afirst elbow and a second elbow; placing a needle, which is attached to aneedle hub, through the catheter hub, the valve, and the catheter tubeso that a tip of the needle extends out the open distal end of thecatheter tube in a ready to use position; and wherein the first elbow islocated in the first through passage and the second elbow is located inthe second through passage in the ready to use position.
 26. The methodof claim 25, wherein the valve comprises a proximally facing wallsurface and wherein the activation end of the valve opener is configuredto urge against the proximally facing wall surface to push the threeflaps against the interior surface of the catheter hub in a usedposition.
 27. The method of claim 25, wherein the first elbow is placedin contact with a perimeter of the first through passage.
 28. The methodof claim 25, wherein the first elbow is placed in contact with theinterior surface of the catheter hub.
 29. The method of claim 25,wherein the first elbow is placed in contact with a perimeter of thefirst through passage and the interior surface of the catheter hub. 30.The method of claim 25, wherein the first elbow is moved into contactwith an edge of the stabilizing ring.
 31. The method of claim 25,wherein the valve comprises a valve disc and a valve skirt extending ina proximal direction of the valve disc and defining a valve cavity. 32.The method of claim 31, wherein the activation end is placed within thevalve cavity in the ready to use position.
 33. The method of claim 25,wherein the second elbow is in contact with the interior surface of thecatheter hub.
 34. The method of claim 33, wherein the nose section has afrustoconical shape.
 35. The method of claim 34, wherein the secondelbow is in contact with a perimeter of the second through passage.